Characterizing the Radiochemical and Radiation Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Ductal Adenocarcinoma
Description:
The objective of this clinical trial is to determine the safety of an intravenously administered radiotracer, RAD301 ([68Ga]-Trivehexin), in either healthy volunteers or patients with pancreatic cancer. All participants will undergo: Screening, which entails physical examination and blood samples for standard blood testing. Participants that successfully pass screening will undergo: Gallium-68 PET scanning procedures, which will occur during a single day (about 5-6 hours). These participants will return to the clinic at 2 weeks for additional safety labs. All scanned participants will also be evaluated by telephone follow up on a weekly basis for 1 month after scanning.
Sponsor:
Radiopharm TheranosticsContacts:
Lionel S Zuckier, MDlzuckier@montefiore.org
(+1) 718 405 8454
Government Study Link:
NCT05799274 - Click here to see study onClinicalTrials.gov
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- Patients may participate regardless of where they are in the course of their illness
- Healthy volunteers should be subjectively healthy and likely to tolerate the imaging procedures
- Patients should have a life expectancy of ≥ 12 weeks
- Patients with a history of histologically or cytologically confirmed PDAC & a recent SoC CT or MRI prior to consent
- Screening laboratory values within 30 days prior to administration of the study drug
- May not have taken any experimental study drugs in the 4 weeks prior to PET scanning
- May not have been exposed to radiation during research producing an Effective Dose of >10 mSv during the last 12 months
- A prior malignancy active within the previous 3 years except for locally curable cancers that have been cured
- Patients who underwent major surgery within 4 weeks of enrollment
- Patients with brain metastases are eligible as long as there is no requirement for high doses of corticosteroids
Patient Education
Patient Education Not Yet Provided
Locations
United States 🇺🇸
Bronx, New York 10461, United States
Principal Investigator
Lionel Zuckier, MD
