Trial Outcomes & Findings for Oxygen Measurements in Subcutaneous Tumors by EPR Oximetry Using OxyChip (NCT NCT02706197)
NCT ID: NCT02706197
Last Updated: 2023-09-21
Results Overview
This is a safety study to demonstrate that the OxyChip will be well-tolerated with minimal risk for complications. All tumors will be excised with the OxyChip in place, and histology will be analyzed for signs of tissue reaction and inflammation adjacent to the OxyChip. pathologic findings associated with the OxyChip are reported.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
From time of implantation procedure to 2 weeks after removal of OxyChip, up to 18 weeks
Results posted on
2023-09-21
Participant Flow
A total of 25 patients were recruited starting from 12/31/2015 to 9/26/2018 in the radiation Oncology Clinic of Dartmouth Hospital.
Out of the 25 enrolled, one participant had signed consent, but withdrew consent prior to any measurement activities.
Participant milestones
| Measure |
IA No Treatment Except Standard-of-care (SOC) Surgery
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IA, patients will not have any cancer therapy prior to removal of the OxyChip and duration of implantation is typically less than 4 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
IB SOC Adjuvant Therapy and SOC Surgery
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IB, patients will have standard of care neoadjuvant chemotherapy or pre-operative radiation therapy during the time that the OxyChip is within the tumor, which is typically 6 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
6
|
|
Overall Study
COMPLETED
|
18
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxygen Measurements in Subcutaneous Tumors by EPR Oximetry Using OxyChip
Baseline characteristics by cohort
| Measure |
IA No Treatment Except Standard-of-care (SOC) Surgery
n=18 Participants
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IA, patients will not have any cancer therapy prior to removal of the OxyChip and duration of implantation is typically less than 4 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
IB SOC Adjuvant Therapy and SOC Surgery
n=6 Participants
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IB, patients will have standard of care neoadjuvant chemotherapy or pre-operative radiation therapy during the time that the OxyChip is within the tumor, which is typically 6 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 Years
n=99 Participants
|
53.5 Years
n=107 Participants
|
61.4 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
6 participants
n=107 Participants
|
24 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From time of implantation procedure to 2 weeks after removal of OxyChip, up to 18 weeksPopulation: The OxyChip could not be found for two participants. The chip was presumed to be lost at the time of surgery for one participant and presumed lost prior to surgery due to rapidly progressive tumor necrosis.
This is a safety study to demonstrate that the OxyChip will be well-tolerated with minimal risk for complications. All tumors will be excised with the OxyChip in place, and histology will be analyzed for signs of tissue reaction and inflammation adjacent to the OxyChip. pathologic findings associated with the OxyChip are reported.
Outcome measures
| Measure |
IA No Treatment Except Standard-of-care (SOC) Surgery
n=16 Participants
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IA, patients will not have any cancer therapy prior to removal of the OxyChip and duration of implantation is typically less than 4 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
IB SOC Adjuvant Therapy and SOC Surgery
n=6 Participants
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IB, patients will have standard of care neoadjuvant chemotherapy or pre-operative radiation therapy during the time that the OxyChip is within the tumor, which is typically 6 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
|---|---|---|
|
Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation
Focal disrupted tissue at edge of tumor with mild nonspecific chronic inflammation
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation
Focal fibrosis, macrophages, and apparent tumor cavitation
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation
Focal organizing fat necrosis
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation
Mild macrophage and foreign body type giant cell reaction at OxyChip site
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation
Mild macrophage predominant chronic inflammatory reaction at needle site
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation
Minimal fat necrosis, macrophage infiltrate immediately surrounding the OxyChip
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation
Minor focal hemorrhage seen adjacent to the deep margin. Very focal collection of macrophages.
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation
Minor hemorrhage at site of injection
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation
Tumor necrosis and mild hemorrhage immediately adjacent to injection site
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation
Tumor necrosis near chip site.
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation
No histologic response seen
|
6 Participants
|
5 Participants
|
|
Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation
Focal fibrosis, a few macrophages adjacent
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From time of implantation procedure to 2 weeks after removal of OxyChipThis is a safety study to demonstrate that the implantation procedure, the OxyChip and any subsequent oxygen measurements will be well-tolerated with minimal risk for complications.
Outcome measures
| Measure |
IA No Treatment Except Standard-of-care (SOC) Surgery
n=18 Participants
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IA, patients will not have any cancer therapy prior to removal of the OxyChip and duration of implantation is typically less than 4 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
IB SOC Adjuvant Therapy and SOC Surgery
n=6 Participants
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IB, patients will have standard of care neoadjuvant chemotherapy or pre-operative radiation therapy during the time that the OxyChip is within the tumor, which is typically 6 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
|---|---|---|
|
Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)
Minor bleeding from implantation needle
|
5 Participants
|
2 Participants
|
|
Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)
Minor bleeding from implantation needle. Mild bruising.
|
2 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)
Discomfort at surgical site
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)
Mild discomfort and bleeding from implantation procedure. Bruising from implantation needle
|
0 Participants
|
1 Participants
|
|
Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)
Mild discomfort from implantation
|
0 Participants
|
1 Participants
|
|
Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)
Minimal bleeding associated with implantation. Mild bruising at needle insertion site
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)
Minor bleeding asociated w implantation. Minor bruising needle ins site. Mild discomfort of L breast
|
0 Participants
|
1 Participants
|
|
Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)
Minor bruising associated with implantation site
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)
No Adverse Events Recorded
|
5 Participants
|
1 Participants
|
|
Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)
Pain and minor bleeding from implantation needle
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)
Pruritis
|
1 Participants
|
0 Participants
|
|
Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)
Pruritis, scalp
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of implantation procedure to time of OxyChip removal; an average of 2 weeks for Phase IA and up to 4 months for Phase IBPopulation: For Arm 1A, 4 subjects were not measured. For Arm 1B, 4 subjects were not measured.
This study will also determine the feasibility of repeated measurements of pO2 in tumors using the OxyChip and EPR oximetry. Tumor pO2 values will be reported in millimeters of mercury (mmHg). Two types of measurements (Data) were made: (i) Baseline tumor pO2 values in patients breathing room air during the first up to 10 min period; and (ii) Hyperoxygenation pO2 values at the end of patients breathing 100% oxygen gas for up to 10 min. The hyperoxygenation was administered immediately following the baseline (room-air breathing) measurements.
Outcome measures
| Measure |
IA No Treatment Except Standard-of-care (SOC) Surgery
n=14 Participants
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IA, patients will not have any cancer therapy prior to removal of the OxyChip and duration of implantation is typically less than 4 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
IB SOC Adjuvant Therapy and SOC Surgery
n=2 Participants
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IB, patients will have standard of care neoadjuvant chemotherapy or pre-operative radiation therapy during the time that the OxyChip is within the tumor, which is typically 6 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
|---|---|---|
|
Measurement of Tumor Partial Pressure of Oxygen (pO2) Levels Using the OxyChip Sensor and EPR Oximetry
Baseline pO2 data
|
17.1 mmHg
Standard Deviation 17.4
|
18.8 mmHg
Standard Deviation 8.8
|
|
Measurement of Tumor Partial Pressure of Oxygen (pO2) Levels Using the OxyChip Sensor and EPR Oximetry
Hyperoxygen pO2 data measured immediately following baseline pO2 data
|
41.7 mmHg
Standard Deviation 35.7
|
42.7 mmHg
Standard Deviation 38.6
|
SECONDARY outcome
Timeframe: From time of preparing the patient for EPR measurement, for example placement of the patient on the bed, attaching the resonator, to completion of the EPR measurements, for example, detaching the resonator and removing the patient off the bed.Population: One subject from IA had Oxychip presumed lost at time of surgery. 4 subjects from each group were not able to be measured.
This study will also determine the feasibility of repeated measurements of oxygen in tumors using the OxyChip and EPR oximetry. We will determine the workflow and time required for each daily oxygen measurement. The measurement time, averaged over multiple measurements on each patient, will be reported as less than or greater than one hour.
Outcome measures
| Measure |
IA No Treatment Except Standard-of-care (SOC) Surgery
n=14 Participants
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IA, patients will not have any cancer therapy prior to removal of the OxyChip and duration of implantation is typically less than 4 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
IB SOC Adjuvant Therapy and SOC Surgery
n=2 Participants
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IB, patients will have standard of care neoadjuvant chemotherapy or pre-operative radiation therapy during the time that the OxyChip is within the tumor, which is typically 6 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
|---|---|---|
|
The Time Required to Complete EPR Oximetry Measurements
Less than 1 Hour
|
14 Participants
|
2 Participants
|
|
The Time Required to Complete EPR Oximetry Measurements
Greater than 1 Hour
|
0 Participants
|
0 Participants
|
Adverse Events
IA No Treatment Except Standard-of-care (SOC) Surgery
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
IB SOC Adjuvant Therapy and SOC Surgery
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IA No Treatment Except Standard-of-care (SOC) Surgery
n=18 participants at risk
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IA, patients will not have any cancer therapy prior to removal of the OxyChip and duration of implantation is typically less than 4 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
IB SOC Adjuvant Therapy and SOC Surgery
n=6 participants at risk
Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IB, patients will have standard of care neoadjuvant chemotherapy or pre-operative radiation therapy during the time that the OxyChip is within the tumor, which is typically 6 weeks but may be up to 52 weeks.
OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
|
|---|---|---|
|
Surgical and medical procedures
Minor Bleeding
|
55.6%
10/18 • Number of events 10 • Adverse events will be evaluated at each study visit, from baseline through 12 months following implantation.
Events were evaluated for associated toxicity using the Common Terminology Criteria for Adverse Events (CTCAE);
|
66.7%
4/6 • Number of events 4 • Adverse events will be evaluated at each study visit, from baseline through 12 months following implantation.
Events were evaluated for associated toxicity using the Common Terminology Criteria for Adverse Events (CTCAE);
|
|
Injury, poisoning and procedural complications
Pain/Discomfort
|
11.1%
2/18 • Number of events 2 • Adverse events will be evaluated at each study visit, from baseline through 12 months following implantation.
Events were evaluated for associated toxicity using the Common Terminology Criteria for Adverse Events (CTCAE);
|
50.0%
3/6 • Number of events 3 • Adverse events will be evaluated at each study visit, from baseline through 12 months following implantation.
Events were evaluated for associated toxicity using the Common Terminology Criteria for Adverse Events (CTCAE);
|
|
Injury, poisoning and procedural complications
Bruising
|
22.2%
4/18 • Number of events 4 • Adverse events will be evaluated at each study visit, from baseline through 12 months following implantation.
Events were evaluated for associated toxicity using the Common Terminology Criteria for Adverse Events (CTCAE);
|
33.3%
2/6 • Number of events 2 • Adverse events will be evaluated at each study visit, from baseline through 12 months following implantation.
Events were evaluated for associated toxicity using the Common Terminology Criteria for Adverse Events (CTCAE);
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
11.1%
2/18 • Number of events 2 • Adverse events will be evaluated at each study visit, from baseline through 12 months following implantation.
Events were evaluated for associated toxicity using the Common Terminology Criteria for Adverse Events (CTCAE);
|
0.00%
0/6 • Adverse events will be evaluated at each study visit, from baseline through 12 months following implantation.
Events were evaluated for associated toxicity using the Common Terminology Criteria for Adverse Events (CTCAE);
|
Additional Information
Periannan (Kupps) Kuppusamy MS, PhD
Program for Clinical Oximetry and Imaging Geisel School of Medicine & Dartmouth Health; Dartmouth College
Phone: 603-646-5490
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place