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Serial FLT PET Imaging in Cancer Patients for Monitoring of Response to Therapy

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ClinicalTrials.gov Identifier: NCT02139150
Recruitment Status : Withdrawn (Lack of accrual)
First Posted : May 15, 2014
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Histologically-confirmed Malignancies Radiation: [18F] FLT Device: PET/CT scans Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Serial FLT PET Imaging in Cancer Patients for Monitoring of Response to Therapy
Study Start Date : May 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

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Arms and Interventions
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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).
 Radiation: [18F] FLT
Device: PET/CT scans


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139150


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Heiko Schöder, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02139150    
Other Study ID Numbers: 14-050
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
FLT PET Imaging
3'deoxy-3' [18F] fluorothymidine ([18F] FLT)
CT
scans
14-050
Additional relevant MeSH terms:
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Neoplasms