Trial Outcomes & Findings for Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma (NCT NCT02645409)
NCT ID: NCT02645409
Last Updated: 2020-02-25
Results Overview
Pathology results will be compared with immunohistochemistry results for each patient. Fluorescence will be looked for in the margins of resection for partial nephectomy and in regional lymph nodes and metastases for radical nephrectomy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
During procedure, an average of 2 hours
Results posted on
2020-02-25
Participant Flow
Participant milestones
| Measure |
Partial Nephrectomy
OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.
OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.
Intraoperative fluorescence imaging system
|
Radical Nephrectomy
OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for radical nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
0
|
|
Overall Study
COMPLETED
|
10
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Partial Nephrectomy
OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.
OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.
Intraoperative fluorescence imaging system
|
Radical Nephrectomy
OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for radical nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Partial Nephrectomy
n=10 Participants
OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.
OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.
Intraoperative fluorescence imaging system
|
Radical Nephrectomy
OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for radical nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.
OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50-70
|
10 Participants
n=99 Participants
|
—
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
—
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
—
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
—
|
10 participants
n=206 Participants
|
|
BMI
|
29.4 kg/m^2
n=99 Participants
|
—
|
29.4 kg/m^2
n=206 Participants
|
|
Pathologic Tumor Stage
pT1a
|
8 Participants
n=99 Participants
|
—
|
8 Participants
n=206 Participants
|
|
Pathologic Tumor Stage
pT3a
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Pathologic Tumor Stage
Benign
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Negative Post-Surgical Margins
|
10 Participants
n=99 Participants
|
—
|
10 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During procedure, an average of 2 hoursPathology results will be compared with immunohistochemistry results for each patient. Fluorescence will be looked for in the margins of resection for partial nephectomy and in regional lymph nodes and metastases for radical nephrectomy.
Outcome measures
| Measure |
Partial Nephrectomy
n=10 Participants
OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.
OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.
Intraoperative fluorescence imaging system
|
|---|---|
|
Number of Participants With Presence of Fluorescence of cT1 RCC in Partial Nephrectomy Specimens
|
10 Participants
|
Adverse Events
Partial Nephrectomy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Radical Nephrectomy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Partial Nephrectomy
n=10 participants at risk
OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.
OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.
Intraoperative fluorescence imaging system
|
Radical Nephrectomy
OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.
OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
10.0%
1/10 • Number of events 1 • 30 days
There are zero participants at risk in the radical nephrectomy arm because no patients enrolled in this arm
|
—
0/0 • 30 days
There are zero participants at risk in the radical nephrectomy arm because no patients enrolled in this arm
|
Additional Information
Courtney Dhondt, Clinical Research Nurse
Indiana University
Phone: 317-274-1791
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place