68Ga-PSMA-11 PET/CT in Patients With Various Types of Cancer
Overview
- Phase
- Early Phase 1
- Intervention
- 68Ga-PSMA-11
- Conditions
- Prostate Cancer
- Sponsor
- First Affiliated Hospital of Fujian Medical University
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Standardized uptake value (SUV)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
To evaluate the potential usefulness of 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions, efficacy assessment and recurrence monitoring in various types of cancer.
Detailed Description
Subjects with various types of cancer underwent 68Ga-PSMA-11 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-PSMA-11 PET/CT were calculated.
Investigators
Weibing Miao, PhD
Director, Department of Nuclear Medicine
First Affiliated Hospital of Fujian Medical University
Eligibility Criteria
Inclusion Criteria
- •(i) adult population (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-PSMA-11 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion Criteria
- •(i) patients with pregnancy; (ii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Arms & Interventions
68Ga-PSMA-11
Each subject receive a single intravenous injection of 68Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.
Intervention: 68Ga-PSMA-11
Outcomes
Primary Outcomes
Standardized uptake value (SUV)
Time Frame: 30 days
Standardized uptake value (SUV) of 68Ga-PSMA-11 for each target lesion of subject or suspected primary tumor or/and metastasis.
Secondary Outcomes
- Diagnostic efficacy(30 days)