- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02139150
Serial FLT PET Imaging in Cancer Patients for Monitoring of Response to Therapy
September 16, 2019 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
This protocol is an "umbrella" or "companion" protocol to be used in conjunction with other protocols that are evaluating treatment response in solid or hematologic malignancies.
The aim of this protocol is to determine if PET imaging with the proliferation marker 18FFLT can monitor changes in FLT uptake parameters, in particular changes in the standardized uptake value (SUV), within tumor target lesions.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
- Women who are pregnant or breast-feeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Serial FLT PET Imaging
Patients 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change from pre- to posttreatment
Time Frame: 4 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Anticipated)
May 1, 2020
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
May 13, 2014
First Submitted That Met QC Criteria
May 13, 2014
First Posted (Estimate)
May 15, 2014
Study Record Updates
Last Update Posted (Actual)
September 17, 2019
Last Update Submitted That Met QC Criteria
September 16, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-050
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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