Trials / Approved For Marketing
Approved For MarketingNCT04452136
Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer
68Ga PSMA-11 in Patients With Intermediate to High-risk Prostate Cancer Before Prostatectomy or With Biochemical Recurrence of Prostate Cancer.
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Jeanne Link · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- —
Summary
This study provides expanded access to radiotracer Gallium 68 (68Ga)-prostate-specific membrane antigen (PSMA)-HBED-CC (68Ga-PSMA-11) with Positron Emission Tomography (PET) imaging for participants with intermediate and high risk prostate cancer before prostatectomy or for suspected biochemical recurrence of their prostate cancer. Compared to conventional imaging, 68Ga PSMA-HBED-CC might improve the ability to localize the sites of recurrent or metastatic disease, which helps with surgical and other treatment planning.
Detailed description
PRIMARY OBJECTIVE: Provide participants with prostate cancer access to 68Ga PSMA-HBED-CC to localize the site of potential metastatic or recurrent disease. OUTLINE: 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.
Conditions
- Prostatic Neoplasms
- Prostatic Diseases
- Prostate Cancer
- Prostate Cancer Metastatic
- Prostate Cancer Recurrent
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 68GA PSMA-HBED-CC | Given IV |
Timeline
- First posted
- 2020-06-30
- Last updated
- 2022-03-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04452136. Inclusion in this directory is not an endorsement.