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SUSPENDED
NCT02130492
PHASE1/PHASE2

A Pilot Study Treatment of Malignant Tumors Using [18F] Fluorodeoxyglucose (FDG)

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

Summary

The objectives of this Pilot study are to investigate the toxicity and safety of high doses of \[18F\]-Fluorodeoxyglucose (FDG) used as a therapeutic agent in patients with advanced stage IV malignant tumors that failed standard of care treatment, have a good performance status and bear radiosensitive tumors with a high \[18F\]-FDG uptake. The investigators hypothesize that \[18F\]FDG may have a significant tumoricidal effect on cancer cells and radionuclide therapy of cancers with high doses of \[18F\]FDG administered as a single dose or in multiple doses (dose fractionation regimen) can be safe and well tolerated with minimal toxicities. Advantages of FDG are its uptake in many different human tumors, its short half-life (110 minutes) and the possibility to monitor its effect closely with the FDG-PET scan. The rationale for using high doses of this radiopharmaceutical agent for treatement is that most malignant lesions have accentuated glucose metabolism, which is mirrored by increased uptake of FDG. Since FDG cannot be metabolized within the cell like glucose, it is effectively confined within the cancer cells; thus, FDG treatment is potentially a novel form of targeted therapy for tumors with increased FDG uptake.

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2014-05

Completion Date

2028-07

Last Updated

2026-05-15

Healthy Volunteers

No

Conditions

Interventions

RADIATION

FDG

The intervention arm consists of treatment with increasing doses of \[18F\]-Fluorodeoxyglucose.

Locations (1)

Weill Medical College of Cornell University

New York, New York, United States