Status:
COMPLETED
PET Imaging With Tc-94m Sestamibi to Assess Resistance to Chemotherapy
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Background: * Tc-94m sestamibi is a radioactive imaging drug approved by the Food and Drug Administration to help photograph and study bodily functions. * Tc-94m sestamibi accumulates in tumor cells ...
Detailed Description
Background: * A pilot study of PET imaging with Tc-94m sestamibi to assess activity of the multidrug transporter, MDR-1 (Multi Drug Resistance Protein 1)/P-glycoprotein, an ATP (adenosine 5'-triphosp...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients must be eligible for enrollment in an active NCI (National Cancer Institute) protocol for treatment of cancer.
- Patients greater than or equal to 18 years old.
- Performance Status ECOG (Eastern Cooperative Oncology Group) 0 - 2.
- Patients must be able to give informed consent.
- Women of childbearing potential must have a negative pregnancy test within 24 hrs of Tc-94m injection.
- Patients who have previously received tariquidar will be eligible, since no study has systematically shown loss of MDR-1 (Multi Drug Resistance Protein 1)/Pgp expression in tumors following exposure to both tariquidar and an anticancer agent.
- An index lesion greater than 1.5 cm will be required to optimize the PET (positron emission imaging) images.
- EXCLUSION CRITERIA:
- Patients who are pregnant or breast-feeding will not be enrolled in order to prevent radiation exposure in the developing fetus or infant.
- Patients weighing greater than 136 kg (the weight limit for the scanner table).
- Patients having only tumor sizes less than 1.5 cm will be excluded.
- HIV (human immunodeficiency virus) positive patients will be excluded to prevent potential drug interactions between tariquidar and antiretroviral agents.
Exclusion
Key Trial Info
Start Date :
May 16 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00082368
Start Date
May 16 2004
End Date
April 14 2014
Last Update
August 17 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892