Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor

NCT ID: NCT05761366

Last Updated: 2024-12-27

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

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-13

Study Completion Date

2025-10-13

Brief Summary

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In this study, Al18F-PSMA-BCH PET/CT will be performed in patients with prostate specific membrane antigen positive tumor, to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.

Detailed Description

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Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors (including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.) , to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.

Conditions

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Malignancy

Keywords

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Malignancy Prostate Specific Membrane Antigen Positive Tumor

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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Al18F-PSMA-BCH PET/CT

Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors.(including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.)

Group Type EXPERIMENTAL

Al18F-PSMA-BCH PET/CT

Intervention Type DRUG

Patients will be intravenously injected with Al18F-PSMA-BCH and undergo PET/CT scan.

Interventions

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Al18F-PSMA-BCH PET/CT

Patients will be intravenously injected with Al18F-PSMA-BCH and undergo PET/CT scan.

Intervention Type DRUG

Other Intervention Names

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18F-Thretide PET/CT

Eligibility Criteria

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Inclusion Criteria

1. Patients with suspected or clearly diagnosed PSMA positive-expressing tumors, including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.
2. Age is 18 or older; No gender limitation.
3. Signed the informed consent.
4. Willing and able to cooperate with all projects in this study.

Exclusion Criteria

1. Patients with serious neurological diseases,or gastrointestinal tract disease, cardiovascular disease, liver disease, kidney disease, blood system disease, endocrine system disease, respiratory system disease, immune deficiency disease, etc
2. Claustrophobia.
3. Pregnant or lactation women.
4. Received experimental drug or device within 1 month.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rong Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and PUMC

Locations

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National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Chaoyang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xin Cheng, MD

Role: CONTACT

Phone: 15120002998

Email: [email protected]

Guozhu Hou, MD

Role: CONTACT

Phone: 15611145656

Email: [email protected]

Facility Contacts

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Xin Cheng, MD

Role: primary

Other Identifiers

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NCC3688

Identifier Type: -

Identifier Source: org_study_id