Clinical trial · Interventional
FLT-PET as an Imaging Biomarker With Temsirolimus, Topotecan, and Bortezomib
FLT-PET as an Imaging Biomarker in Patients Receiving the Combination of Cell Cycle Inhibitors Temsirolimus, Topotecan, and Bortezomib
NCT01143779CI-TRIAL-00055786completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if an imaging solution, \[F-18\]-fluoro-L-thymidine (FLT), when used with a positron emission tomography (PET) scan, can help doctors to better see changes in the growth of tumors in the body. Researchers want to learn if FLT-PET scans can show an early response to chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLT-PET | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FLT-PET
- description
- FLT-PET scan uses the FLT solution (dosage of FLT in range between 1 and 10 mCi) with imaging performed 60-90 minutes after FLT intravenous injection.
- interventionNames
- Drug: FLT-PET
Primary outcomes (1)
- measure
- Patient Standardized Uptake Value (SUV)
- timeFrame
- Cycle 1, Day 21
- description
- SUV measured on continuous scale at two specified time points (baseline and post-treatment phase, cycle 1, day 19-21).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients enrolled on Protocol 2008-0425: "A Phase I Study of Temsirolimus, Topotecan, and Bortezomib in Patients with Advanced Malignancy" or Protocol 2012-0061: "A Phase I Trial of Bevacizumab, Temsirolimus Alone and in Combination with Valproic Acid or Cetuximab in Patients with Advanced Malignancy" are eligible. These patients must have met the inclusion and exclusion criteria for that protocol. 2. Women of child-bearing potential (as defined as women who are not post-menopausal for 12 months or who have had no previous surgical sterilization) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose. 3. Ability to understand and the willingness to sign a written informed consent document. 4. Patients must be at least 18 years of age Exclusion Criteria: 1. Pregnant or breast-feeding women. 2. History of hypersensitivity to 3'-deoxy-3'-18F-fluorothymidine (18F- FLT) or any component of the formulation.
References
Publications (0)
Data not yet available
No reference posted for this study.