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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    PET Imaging With Tc-94m Sestamibi
STARTED   12 
COMPLETED   11 
NOT COMPLETED   1 
Not treated-pt had poor IV access                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Baseline Measures
   PET Imaging With Tc-94m Sestamibi 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      11  91.7% 
>=65 years      1   8.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.82  (8.11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  33.3% 
Male      8  66.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2  16.7% 
Not Hispanic or Latino      10  83.3% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
 
United States   12 
Performance Status: Eastern Cooperative Oncology Group (ECOG) [1] 
[Units: Participants]
Count of Participants
 
Performance status: 0   2 
Performance status: 1   9 
Performance status: 2   1 
Performance status: 3   0 
[1] 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 
[Units: Participants]
Count of Participants
 
Colorectal cancer   4 
Pancreatic cancer   2 
Small cell lung cancer   2 
Non-small cell lung cancer   1 
Esophageal cancer   1 
Prostate cancer   1 
Ovarian cancer   1 
Prior Chemotherapy 
[Units: Prior therapies]
Mean (Full Range)
 3.5 
 (1 to 6) 


  Outcome Measures

1.  Primary:   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.   [ Time Frame: 3 days ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 69 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The lack of flexibility around patient chemotherapy schedules made the protocol difficult to conduct. Future studies should make imaging integral to the treatment protocol .


  More Information

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
e-mail: peter_choyke@nih.gov


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