FLT-PET as an Imaging Biomarker With Temsirolimus, Topotecan, and Bortezomib
1 other identifier
interventional
3
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2010
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 11, 2010
CompletedFirst Posted
Study publicly available on registry
June 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2021
CompletedJanuary 4, 2022
January 1, 2022
11.6 years
June 11, 2010
January 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Standardized Uptake Value (SUV)
SUV measured on continuous scale at two specified time points (baseline and post-treatment phase, cycle 1, day 19-21).
Cycle 1, Day 21
Study Arms (1)
FLT-PET
EXPERIMENTALFLT-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.
Interventions
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.
Eligibility Criteria
You may not qualify if:
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must be at least 18 years of age
- Pregnant or breast-feeding women.
- History of hypersensitivity to 3'-deoxy-3'-18F-fluorothymidine (18F- FLT) or any component of the formulation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarina Piha-Paul, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2010
First Posted
June 14, 2010
Study Start
June 1, 2010
Primary Completion
December 27, 2021
Study Completion
December 27, 2021
Last Updated
January 4, 2022
Record last verified: 2022-01