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68Ga-PSMA-11 PET/CT in Patients With Various Types of Cancer

F

Fujian Medical University (FJMU)

Status and phase

Enrolling
Early Phase 1

Conditions

Prostate Cancer
Positron-Emission Tomography

Treatments

Drug: 68Ga-PSMA-11

Study type

Interventional

Funder types

Other

Identifiers

NCT04831541
FirstAHFujian6

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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-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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

600 participants in 1 patient group

68Ga-PSMA-11
Experimental group
Description:
Each subject receive a single intravenous injection of 68Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.
Treatment:
Drug: 68Ga-PSMA-11

Trial contacts and locations

1

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Central trial contact

Weibing Miao, MD; Shaoming Chen, MD

Data sourced from clinicaltrials.gov

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