Study Stopped
Lack of accrual
Serial FLT PET Imaging in Cancer Patients for Monitoring of Response to Therapy
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to see if PET/CT scans that use a radioactive substance called \[18F\] fluorothymidine (FLT), can detect and monitor changes in the tumor. Radioactive substances are used with PET/CT scans to "see" cancer cells, and are also called radiotracers. FLT is a new radiotracer that has been given to people in prior studies. FLT PET/CT is an experimental scan unlike FDG (fluorodeoxyglucose) PET scan which is a standard clinical scan and is commonly used. The investigators would like to know if there is any evidence of early treatment response by obtaining FLTPET/ CT scans before and after treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 13, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedSeptember 17, 2019
September 1, 2019
6 years
May 13, 2014
September 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change from pre- to posttreatment
We will describe the distribution of the change and explore if it is associated with the findings of standard-of-care imaging such as FDG-PET or CT/MRI using rank based methods such as Spearman correlation and the signed-ranks test. In addition we will also explore the value of the change in the FLT metrics in predicting the clinical outcome using logistic regression (for response) and proportional hazards regression (for progression and survival).
4 years
Study Arms (1)
Serial FLT PET Imaging
EXPERIMENTALPatients will receive a target injection of up to 10 mCi of FLT. Optionally, dynamic PET imaging over a chosen index lesion (based on size and/or high FDG-avidity on preceding CT and/or FDG PET/CT scans done for clinical purpose such as staging), may be performed. Otherwise, static PET images are obtained at approximately 60 min (+15 min) post FLT injection. In general this "body" scan will cover at least the region from skull base to the upper thigh for extracranial malignancies; depending on the specific location, extremities maybe also be scanned (e.g., extremity sarcoma), or the scan may be restricted to the brain (e.g. glioma).
Interventions
Eligibility Criteria
You may qualify if:
- Patients with histologically-confirmed (confirmation done at MSKCC) malignancies.
- Patients who have consented to a therapeutic protocol for the treatment of their cancer.
- Patients must be ≥ 18 years old.
You may not qualify if:
- Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
- Women who are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heiko Schöder, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2014
First Posted
May 15, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
September 17, 2019
Record last verified: 2019-09