68Ga-PSMA PET-CT Scan for Diagnosis and Management of Prostate Cancer (PSMA)
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|ClinicalTrials.gov Identifier: NCT02282137|
Recruitment Status : Recruiting
First Posted : November 4, 2014
Last Update Posted : August 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 68Ga-PSMA||Phase 2|
68Ga-PSMA-11 is a radioactive imaging contrast agent for use in PET CT scan that seeks to identify prostate cancer cells that have a specific protein target called prostate-specific membrane antigen (PSMA) on their surface. PET and CT make computerizing pictures of areas inside the body where the radioactive substance is lighting up. 68Ga-PSMA-11 PET / CT may be able to see smaller tumors than standard imaging and may help determine whether prostate cancer has come back and where it is in the body.
A 68Ga-PSMA-11 PET / CT scan may help doctors to better detect the location, extent, and characteristics of the tumor, allowing improved planning of subsequent therapy
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||208 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||68Ga-PSMA (ProstaMedix™) PET-CT Scan for Diagnosis and Management of Prostate Cancer|
|Actual Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Evaluation of concordance and discordance between the results of 68Ga-PSMA PET/CT and other available conventional imaging modalities (such as CT, MRI, FDG, NaF scan), histology or follow up.
Patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.
Other Name: 68Ga-HBED-CC-PSMA
- The sensitivity of 68Ga-PSMA-11 PET for detection of tumor location. [ Time Frame: 12 months ]The sensitivity of 68Ga-PSMA-11 PET to detect tumor location and metastases in patients with biopsy confirmed diagnosis.tumor location confirmed by histopathology/biopsy and conventional imaging follow-up.
- Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value [ Time Frame: 12 months ]Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value (0.2 - <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - <5.0, 5.0).
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): NCT02282137
|Contact: Susan Cork||713-781-6200 ext 3203||Scork@exceldiagnostics.com|
|Contact: Rodolfo Nunez, MD||713-781-6200 ext 3225||Rnunez@exceldiagnostics.com|
|United States, Texas|
|Radio- Isotope Therapy of America||Recruiting|
|Houston, Texas, United States, 77042|
|Contact: Susan Cork 713-341-3203 firstname.lastname@example.org|
|Contact: Ayman Gaber, MBBCh-MS 713-781-6200 ext 3242 email@example.com|
|Principal Investigator: Rodolfo Nunez, MD|
|Sub-Investigator: Ebrahim S Delpassand, MD-FACNM|
|Sub-Investigator: Ayman Gaber, MBBCh-MS|
|Principal Investigator:||Rodolfo Nunez, MD||Excel Diagnostics and Nuclear Oncology Center|