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

F

Fujian Medical University (FJMU)

Status and phase

Unknown
Early Phase 1

Conditions

Metastasis
Tumor
Positron-Emission Tomography

Treatments

Diagnostic Test: 68Ga-BNU-PSMA

Study type

Interventional

Funder types

Other

Identifiers

NCT04525612
FirstAHFujian5

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

68Ga-BNU-PSMA
Experimental group
Description:
Each subject receive a single intravenous injection of 68Ga-BNU-PSMA, and undergo PET/CT imaging within the specificed time.
Treatment:
Diagnostic Test: 68Ga-BNU-PSMA

Trial contacts and locations

1

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Central trial contact

Weibing Miao, MD; Shaobo Yao, MD

Data sourced from clinicaltrials.gov

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