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PET Imaging With Tc-94m Sestamibi to Assess Resistance to Chemotherapy

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ClinicalTrials.gov Identifier: NCT00082368
Recruitment Status : Completed
First Posted : May 6, 2004
Results First Posted : May 4, 2015
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Choyke, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Cancer
Interventions Drug: Tariquidar
Drug: Tc-94m Sestamibi
Enrollment 12

Recruitment Details  
Pre-assignment Details  
Arm/Group Title PET Imaging With Tc-94m Sestamibi
Hide Arm/Group Description

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

Period Title: Overall Study
Started 12
Completed 11
Not Completed 1
Reason Not Completed
Not treated-pt had poor IV access             1
Arm/Group Title PET Imaging With Tc-94m Sestamibi
Hide Arm/Group Description

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 Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  91.7%
>=65 years
1
   8.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
54.82  (8.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic or Latino
2
  16.7%
Not Hispanic or Latino
10
  83.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   8.3%
Native Hawaiian or Other Pacific Islander
1
   8.3%
Black or African American
3
  25.0%
White
7
  58.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
 100.0%
Performance Status: Eastern Cooperative Oncology Group (ECOG)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Performance status: 0
2
  16.7%
Performance status: 1
9
  75.0%
Performance status: 2
1
   8.3%
Performance status: 3
0
   0.0%
[1]
Measure Description: ECOG Performance Status: Grade 0 is normal activity. Fully active, able to carry on all pre-disease performance without restriction. Grade 1 is symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work). Grade 2 is in bed <50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Grade 3 is in bed >50% of the time. Capable of only limited self-care. Grade 4 is 100% bedridden. Completely disabled. Grade 5 is dead.
Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Colorectal cancer
4
  33.3%
Pancreatic cancer
2
  16.7%
Small cell lung cancer
2
  16.7%
Non-small cell lung cancer
1
   8.3%
Esophageal cancer
1
   8.3%
Prostate cancer
1
   8.3%
Ovarian cancer
1
   8.3%
Prior Chemotherapy  
Mean (Full Range)
Unit of measure:  Prior therapies
Number Analyzed 12 participants
3.5
(1 to 6)
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PET Imaging With Tc-94m Sestamibi
Hide Arm/Group Description:

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 Number of Participants Analyzed 12
Mean (Full Range)
Unit of Measure: % change in Tc-94m Sestamibi SUVmax
44
(-10 to 153)
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame 69 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PET Imaging With Tc-94m Sestamibi
Hide Arm/Group Description:

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 Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
8
Time Frame 69 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PET Imaging With Tc-94m Sestamibi
Hide Arm/Group Description

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

All-Cause Mortality
PET Imaging With Tc-94m Sestamibi
Affected / at Risk (%)
Total   0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PET Imaging With Tc-94m Sestamibi
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PET Imaging With Tc-94m Sestamibi
Affected / at Risk (%) # Events
Total   8/12 (66.67%)    
Blood and lymphatic system disorders   
Low Hemoglobin  1  4/12 (33.33%)  5
Low Leukocytes (total WBC)  1  1/12 (8.33%)  1
Lymphopenia  1  1/12 (8.33%)  1
Low Neutrophils/granulocytes (ANC/AGC)  1  1/12 (8.33%)  4
Low Platelets  1  1/12 (8.33%)  1
Metabolism and nutrition disorders   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  2/12 (16.67%)  2
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  2/12 (16.67%)  2
Albumin, serum-low (hypoalbuminemia)  1  4/12 (33.33%)  5
Alkaline phosphatase  1  1/12 (8.33%)  1
Bilirubin (hyperbilirubinemia)  1  1/12 (8.33%)  2
Calcium, serum-high (hypercalcemia)  1  1/12 (8.33%)  1
Creatinine  1  1/12 (8.33%)  2
Magnesium, serum-high (hypermagnesemia)  1  1/12 (8.33%)  1
Magnesium, serum-low (hypomagnesemia)  1  2/12 (16.67%)  2
Potassium, serum-low (hypokalemia)  1  1/12 (8.33%)  2
Sodium, serum-low (hyponatremia)  1  1/12 (8.33%)  1
Uric acid, serum-high (hyperuricemia)  1  1/12 (8.33%)  1
Nervous system disorders   
Pain::Head/headache  1  1/12 (8.33%)  1
1
Term from vocabulary, CTCv3.0
Indicates events were collected by systematic assessment
The lack of flexibility around patient chemotherapy schedules made the protocol difficult to conduct. Future studies should make imaging integral to the treatment protocol .
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Peter Choyke
Organization: National Cancer Institute
Phone: 301-402-8409
Publications:
Responsible Party: Peter Choyke, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00082368     History of Changes
Obsolete Identifiers: NCT00086853
Other Study ID Numbers: 040177
04-C-0177
First Submitted: July 7, 2006
First Posted: May 6, 2004
Results First Submitted: April 15, 2015
Results First Posted: May 4, 2015
Last Update Posted: August 17, 2017