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Clinical Trials/NCT02139150
NCT02139150
Withdrawn
Not Applicable

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

Memorial Sloan Kettering Cancer Center1 site in 1 countryMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Histologically-confirmed Malignancies
Sponsor
Memorial Sloan Kettering Cancer Center
Locations
1
Primary Endpoint
change from pre- to posttreatment
Status
Withdrawn
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
May 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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).

Study Sites (1)

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