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NCT04525612 Clinical Trial

68Ga-BNU-PSMA PET/CT in Patients With Various Types of Cancer

Tumor Clinical Trial

Official title:
68Ga-BNU-PSMA PET/CT in Patients With Various Types of Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04525612
Other study ID # FirstAHFujian5
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date August 21, 2020
Est. completion date December 30, 2022

Study information
Verified date September 2020
Source First Affiliated Hospital of Fujian Medical University
Contact Weibing Miao, MD
Phone 86-0591-87981618
Email miaoweibing@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the potential usefulness of 68Ga-BNU-PSMA positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Description:

Subjects with various types of cancer underwent 68Ga-BNU-PSMA 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-BNU-PSMA PET/CT were calculated.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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-BNU-PSMA 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; (v) healthy volunteers(aged 18 years or order).

Exclusion Criteria:

- (i) patients with pregnancy; (ii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 68Ga-BNU-PSMA
Each patient receive a single intravenous injection of 68Ga-BNU-PSMA, and undergo PET/CT scan within specified time.

Locations
Country Name City State
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Standardized uptake value (SUV) Standardized uptake value (SUV) of 68Ga-BNU-PSMA for each target lesion of subject or suspected primary tumor or/and metastasis. 30 days
Secondary Diagnostic efficacy The sensitivity, specificity and accuracy of 68Ga-BNU-PSMA PET/CT were calculated. 30 days
Secondary Diagnostic efficacy The positive predictive value (PPV), negative predictive value (NPV) 30 days
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