Trial Outcomes & Findings for PET Imaging With Tc-94m Sestamibi to Assess Resistance to Chemotherapy (NCT NCT00082368)
NCT ID: NCT00082368
Last Updated: 2017-08-17
Results Overview
Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. Significant increase in the SUV in tumor is +25% over baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
3 days
Results posted on
2017-08-17
Participant Flow
Participant milestones
| Measure |
PET Imaging With Tc-94m Sestamibi
Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging
Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.
Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
PET Imaging With Tc-94m Sestamibi
Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging
Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.
Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan
|
|---|---|
|
Overall Study
Not treated-pt had poor IV access
|
1
|
Baseline Characteristics
PET Imaging With Tc-94m Sestamibi to Assess Resistance to Chemotherapy
Baseline characteristics by cohort
| Measure |
PET Imaging With Tc-94m Sestamibi
n=12 Participants
Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging
Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.
Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
54.82 years
STANDARD_DEVIATION 8.11 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
|
Performance Status: Eastern Cooperative Oncology Group (ECOG)
Performance status: 0
|
2 Participants
n=99 Participants
|
|
Performance Status: Eastern Cooperative Oncology Group (ECOG)
Performance status: 1
|
9 Participants
n=99 Participants
|
|
Performance Status: Eastern Cooperative Oncology Group (ECOG)
Performance status: 2
|
1 Participants
n=99 Participants
|
|
Performance Status: Eastern Cooperative Oncology Group (ECOG)
Performance status: 3
|
0 Participants
n=99 Participants
|
|
Histology
Colorectal cancer
|
4 Participants
n=99 Participants
|
|
Histology
Pancreatic cancer
|
2 Participants
n=99 Participants
|
|
Histology
Small cell lung cancer
|
2 Participants
n=99 Participants
|
|
Histology
Non-small cell lung cancer
|
1 Participants
n=99 Participants
|
|
Histology
Esophageal cancer
|
1 Participants
n=99 Participants
|
|
Histology
Prostate cancer
|
1 Participants
n=99 Participants
|
|
Histology
Ovarian cancer
|
1 Participants
n=99 Participants
|
|
Prior Chemotherapy
|
3.5 prior therapies
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 daysSestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. Significant increase in the SUV in tumor is +25% over baseline.
Outcome measures
| Measure |
PET Imaging With Tc-94m Sestamibi
n=12 Participants
Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging
Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.
Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan
|
|---|---|
|
Percent Change in Tc-94m Sestamibi Body Weight Standardized Uptake Value (SUV) Maximum in Tumor Tissue Before and After Administration of Tariquidar, a P-glycoprotein Antagonist.
|
44 % change in Tc-94m Sestamibi SUVmax
Interval -10.0 to 153.0
|
SECONDARY outcome
Timeframe: 69 monthsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
PET Imaging With Tc-94m Sestamibi
n=12 Participants
Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging
Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.
Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan
|
|---|---|
|
Number of Participants With Adverse Events
|
8 participants
|
Adverse Events
PET Imaging With Tc-94m Sestamibi
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PET Imaging With Tc-94m Sestamibi
n=12 participants at risk
Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging
Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.
Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
16.7%
2/12 • Number of events 2 • 69 months
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
16.7%
2/12 • Number of events 2 • 69 months
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
33.3%
4/12 • Number of events 5 • 69 months
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
8.3%
1/12 • Number of events 1 • 69 months
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
8.3%
1/12 • Number of events 2 • 69 months
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
8.3%
1/12 • Number of events 1 • 69 months
|
|
Metabolism and nutrition disorders
Creatinine
|
8.3%
1/12 • Number of events 2 • 69 months
|
|
Blood and lymphatic system disorders
Low Hemoglobin
|
33.3%
4/12 • Number of events 5 • 69 months
|
|
Blood and lymphatic system disorders
Low Leukocytes (total WBC)
|
8.3%
1/12 • Number of events 1 • 69 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.3%
1/12 • Number of events 1 • 69 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
8.3%
1/12 • Number of events 1 • 69 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
16.7%
2/12 • Number of events 2 • 69 months
|
|
Blood and lymphatic system disorders
Low Neutrophils/granulocytes (ANC/AGC)
|
8.3%
1/12 • Number of events 4 • 69 months
|
|
Nervous system disorders
Pain::Head/headache
|
8.3%
1/12 • Number of events 1 • 69 months
|
|
Blood and lymphatic system disorders
Low Platelets
|
8.3%
1/12 • Number of events 1 • 69 months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
8.3%
1/12 • Number of events 2 • 69 months
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
8.3%
1/12 • Number of events 1 • 69 months
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
8.3%
1/12 • Number of events 1 • 69 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place