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

NCT ID: NCT02139150

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2020-05-31

Brief Summary

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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

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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.

Conditions

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Histologically-confirmed Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

[18F] FLT

Intervention Type RADIATION

PET/CT scans

Intervention Type DEVICE

Interventions

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[18F] FLT

Intervention Type RADIATION

PET/CT scans

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heiko Schöder, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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14-050

Identifier Type: -

Identifier Source: org_study_id

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