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

NCT ID: NCT04831541

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Positron-Emission Tomography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-PSMA-11

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

Group Type EXPERIMENTAL

68Ga-PSMA-11

Intervention Type DRUG

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

Interventions

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68Ga-PSMA-11

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

Intervention Type DRUG

Other Intervention Names

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Diagnostic Test: PET/CT scan

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Weibing Miao, PhD

Director, Department of Nuclear Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weibing Miao, MD

Role: CONTACT

86-0591-87981618

Shaoming Chen, MD

Role: CONTACT

86-0591-87981619

Facility Contacts

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Weibing Miao, MD

Role: primary

+86 591 87981618

Kaixian Lin, MD

Role: backup

+86 591 87981619

Other Identifiers

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FirstAHFujian6

Identifier Type: -

Identifier Source: org_study_id

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