PET Imaging With Tc-94m Sestamibi to Assess Resistance to Chemotherapy
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00082368 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tariquidar (Drug); Tc-94m Sestamibi (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
44 | — |
| SECONDARY Number of Participants With Adverse Events |
8 | — |
Summary
Eligibility Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00082368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.