68Ga-PSMA PET-CT Scan for Diagnosis and Management of Prostate Cancer
Status: | Completed |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/2/2016 |
Start Date: | April 2015 |
End Date: | December 2015 |
Contact: | Tannaz Armaghany, MD |
Email: | tarm@westcca.com |
Phone: | 713-523-6700 |
68Ga-PSMA (ProstaMedix™) PET-CT Scan for Diagnosis and Management of Prostate Cancer
Single center, Prospective, Phase II expanded access clinical studies of 68Ga-PSMA
(ProstaMedix TM) used for diagnosis and management of patients with prostate cancer.
(ProstaMedix TM) used for diagnosis and management of patients with prostate cancer.
The goal of this trial is to evaluate patients with suspected prostate cancer recurrence and
non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance
imaging (MRI). 68Ga-PSMA PET/CT imaging may help identify potential sites of prostate cancer
recurrence for subsequent histologic confirmation. Suspected prostate recurrence will be
based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.
non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance
imaging (MRI). 68Ga-PSMA PET/CT imaging may help identify potential sites of prostate cancer
recurrence for subsequent histologic confirmation. Suspected prostate recurrence will be
based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.
Inclusion Criteria:
- Signed informed consent.
- Male patients, aged 18 years.
- Histologically and/or clinically confirmed and/or suspicious of Prostate cancer.
- Recent Blood test results up to 4.6 weeks as follows: WBC: >2*109/L, Haemoglobin:
>8.0g/Dl, Platelets: >50x109/L
Exclusion Criteria:
- Known hypersensitivity to 68Ga, HBED-CC, PSMA or to any of the excipients of
68Ga-PSMA.
- Current somatic or psychiatric disease/condition that may interfere with the
objectives and assessments of the study
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