[Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients

NCT04693169 | Unknown

• 1 other identifier: 2020KT154
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the radioactive uptake of \[Al 18 F\]PSMA137 in PCa patients, and evaluate the ability of \[Al 18 F\]PSMA137 to detect PSMA overexpression in PCa patients (especially those with recurrent or advanced PCa).To provide an approach for screening patients high expression of PSMA, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the individualized antitumor treatment of targeted drugs.

Conditions

Prostate Cancer

Keywords

PSMA

Outcome Measures

Primary Outcomes (1)

• SUV（standardized uptake value）

  SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （\[Al18F\]PSMA137） in the primary and metastatic tumor lesions by measuring SUV on PET/CT

  2 years

Study Arms (1)

[Al18F]PSMA137 PET/CT imaging

EXPERIMENTAL

All study participants will be allocated to this arm (single-arm study).Study participants will undergo \[Al18F\]PSMA137 PET/CT scans.

Drug: 11C-Choline

Interventions

11C-Choline DRUG

1、PSMA137 labeled with \[Al18F\] will be used as a molecular imaging tracer for PET/CT scanning。 2、11C-choline (0.05-0.1mCi/kg) was injected intravenously in a week after the \[Al18F\]PSMA137 PET/CT examination, and imaging of the head and body cadres was performed 20 min after the injection using Philips Gemini TF16 or Siemens Biograph M-CT flow PET/CT

Also known as: 11C-CH

[Al18F]PSMA137 PET/CT imaging

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men over 18 years of age need to undergo \[Al18F\]PSMA137 PET/CT examination for suspected prostate cancer.
• The patients can fully understand and voluntarily participate in this experiment, and sign the informed consent.

You may not qualify if:

• Significant hepatic or renal dysfunction;
• Patients with malignant tumors other than prostate cancer within 2 years;
• Ready to pregnant;
• The patient can not tolerate all clinical tests.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: January 15, 2021
• Primary Completion: June 12, 2024
• Study Completion: December 12, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)