Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04452136|
Expanded Access Status : Available
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment|
|Prostatic Neoplasms Prostatic Diseases Prostate Cancer Prostate Cancer Metastatic Prostate Cancer Recurrent||Drug: 68GA PSMA-HBED-CC|
Provide participants with prostate cancer access to 68Ga PSMA-HBED-CC to localize the site of potential metastatic or recurrent disease.
Eligible participants will be intravenously administered 68Ga PSMA-HBED-CC at a dose of 3-7 mCi (111 - 259 MBq), target 5 mCi. The estimated uptake time of the study agent is 75 minutes ± 25 minutes. The targeted uptake time is 60 minutes, with an acceptable range of 50-100 minutes. Following the PET scan with the study agent, participants will undergo either surgical management or treatment for metastatic disease in accordance with institutional standards.
Patients will be observed for 2 hours after injection of the radiotracer, and will be followed-up 1-3 days post injection with a phone call.
|Study Type :||Expanded Access|
|Expanded Access Type :||Intermediate-size Population|
|Official Title:||68Ga PSMA-11 in Patients With Intermediate to High-risk Prostate Cancer Before Prostatectomy or With Biochemical Recurrence of Prostate Cancer.|
- Drug: 68GA PSMA-HBED-CC
Given IVOther Name: 68Ga-PSMA-11
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): NCT04452136
|Contact: Libby Mirande||503-494-4740||Radresearch@ohsu.edu|
|United States, Oregon|
|OHSU Knight Cancer Institute||Available|
|Portland, Oregon, United States, 97239|
|Contact: Libby Mirande 503-494-4740 Radresearch@ohsu.edu|
|Principal Investigator: Nadine Mallak, M.D.|
|Principal Investigator:||Nadine Mallak, M.D.||OHSU Knight Cancer Institute|