A Pilot Study Treatment of Malignant Tumors Using [18F] Fluorodeoxyglucose (FDG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02130492|
Recruitment Status : Suspended (The study has moved to another institution and will re-open in the near future)
First Posted : May 5, 2014
Last Update Posted : September 30, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Radiosensitive Stage IV Solid and Hematological Tumors With High FDG Uptake Not Responding to Standard of Care Lung Cancer, Head and Neck Cancer, Breast Cancer, Gastric Cancer, Pancreatic Cancer, Colon Cancer, Lymphomas, Sarcomas, Etc||Radiation: FDG||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Treatment of Malignant Tumors Using [18F] Fluorodeoxyglucose (FDG)|
|Actual Study Start Date :||May 2014|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
Experimental: FDG arm
Patients will receive increasing doses of FDG.
The intervention arm consists of treatment with increasing doses of [18F]-Fluorodeoxyglucose.
Other Name: [18F]-Fluorodeoxyglucose
- Number of Participants with Serious and Non-Serious Adverse Events and Type of Serious and Non-Serious Adverse Events [ Time Frame: Up to 1 year post administration of FDG ]Evaluate for any possible side effects related to the high doses FDG administered with therapeutic intent
- Efficacy Outcome Measure [ Time Frame: Up to one year post FDG treatment ]Tumor responses in terms of size (CT scans) or FDG uptake (FDG-PET scans) will be carefully recorded and monitored using RECIST Criteria.
- FDG Dosimetry for Normal Organs, Tumors and/or Metastases [ Time Frame: 8 hours for each patient enrolled ]Evaluate dosimetry for FDG administered at high doses
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130492
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10024|
|Principal Investigator:||Doru Paul, MD||Weill Medical College of Cornell University|