Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT02130492
Brief 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.
Detailed Description:
Photons, electrons and protons have therapeutic use however positrons have only been used for diagnostic imaging purposes.. The energies of positrons (β+) from F-18 (0.633 MeV) and electrons (β-) from I-131 (0.606 MeV) are very close and have similar equilibrium dose constants. Since \[18F\]- fluorodeoxyglucose (18F-FDG) clears rapidly from circulation, administration of 37-74 BGq (1-2 Ci) of 18F-FDG is relatively safe from an internal radiation dosimetry point of view. We initiated a phase I dose escalation study to assess the safety, toxicity, and potential therapeutic utility of administering high doses of 18F-FDG delivered over a 1 to 5 day period in patients with advanced lymphomas and solid tumors refractory to standard of care treatment (SCT). There will also be a Phase 2 portion of the study.
Study:
NCT02130492
Study Brief:
Protocol Section:
NCT02130492