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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02139150
Enrollment
0
Registered
2014-05-15
Start date
2014-05-31
Completion date
2020-05-31
Last updated
2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Histologically-confirmed Malignancies

Keywords

FLT PET Imaging, 3'deoxy-3' [18F] fluorothymidine ([18F] FLT), CT, scans, 14-050

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.

Interventions

RADIATION[18F] FLT

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
change from pre- to posttreatment4 yearsWe 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026