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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Withdrawn

Conditions: Histologically-confirmed Malignancies

Treatments: Device: PET/CT scans; Radiation: [18F] FLT

Study type: Interventional

Funder types: Other

Identifiers

NCT02139150

14-050

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Serial FLT PET Imaging

Experimental group

Description:

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).

Treatment:

Radiation: [18F] FLT

Device: PET/CT scans