A Study of the Value of Hybrid PET/MR and PET/CT in Prostate Cancer

February 13, 2023 updated by: Xiaoli Lan, Wuhan Union Hospital, China

A Prospective Study of the Value of Hybrid PET/MR and PET/CT in Prostate Cancer

According to the latest data from the China National Cancer Center, prostate cancer has become the most common tumor in the urinary system since 2008. However, conventional imaging techniques including transrectal ultrasound , computed tomography and bone scintigraphy are not sensitive or specific. About 40% of resectable lesions cannot be detected by these techniques. Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and staging of prostate cancer. Recently, prostate-specific membrane antigen (PSMA) as a new novel positron tracer has shown to be effective to detect primary lesions, recurrent and metastatic lesions of prostate cancer. In this prospective study, the investigators will use the most advanced imaging equipments, integrated PET/MR, and PET/CT with prostate cancer-specific imaging agent 68Ga-PSMA and conventional imaging agent [F-18]fluorodeoxyglucose to image patients with or suspected of prostate cancer, the aim is to explore the value of hybrid PET/MR and PET/CT in prostate cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

According to the latest data from the China National Cancer Center, prostate cancer has become the most common tumor in the urinary system since 2008. However, conventional imaging techniques including transrectal ultrasound , computed tomography and bone scintigraphy are not sensitive or specific. About 40% of resectable lesions cannot be detected by these techniques. Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and staging of prostate cancer. Recently, prostate-specific membrane antigen (PSMA) as a new novel positron tracer has shown to be effective to detect primary lesions, recurrence and metastatic lesions of prostate cancer. In this prospective study, the investigators will use the most advanced imaging equipment, integrated PET/MR, and PET/CT with prostate cancer-specific imaging agent 68Ga-PSMA and conventional imaging agent [F-18]fluorodeoxyglucose to image patients. For patients suspected of or diagnosed with prostate cancer, the investigators aim to evaluate the roles of integrated PET/MR and PET/CT in differential diagnosis, detecting primary and metastatic lesions, guilding biopsy, staging and determining treatment plan prior to treatment; for the patients with a history of prostate cancer, the aim is to evaluate the value of integrated PET/MR and PET/CT for treatment response assessment, detection of recurrences and metastatic lesions.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Xiaoli Lan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Central China

Description

Inclusion Criteria:

  • Patients suspected of or diagnosed with prostate cancer

Exclusion Criteria:

  • Acute systemic diseases and electrolyte disorders
  • Patients with known malignancy in other organs
  • Patients with severe claustrophobia or unstable vital sigh
  • Other serious comorbidities evaluated by primary investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary diagnosis and staging
Patients suspected of or diagnosed with prostate cancer who want a differential diagnosis and staging by 68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT before treatment
Diagnostic test: 68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT
0.05-0.06 mCi per kilogram bodyweight of 68Ga-PSMA, 0.1-0.15 mCi per kilogram bodyweight of 18F-FDG will be injected intravenously prior to imaging
Evaluation of recurrence
Patients with a history of prostate cancer and elevated PSA level after treatment, who need to determining whether or not there are recurrences/metastatic lesions and its locations by 68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT
Diagnostic test: 68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT
0.05-0.06 mCi per kilogram bodyweight of 68Ga-PSMA, 0.1-0.15 mCi per kilogram bodyweight of 18F-FDG will be injected intravenously prior to imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for initial diagnosis and staging
Time Frame: up to 2 years
For patient without any treatment, Initial diagnosis and staging results of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT will be compared to pathology, clinical and follow-up result. Evaluation of the concordance between 68Ga-PSMA PET/MR and PET/CT, the differences between 68Ga-PSMA and 18F-FDG.
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for recurrence detection
Time Frame: up to 2 years
For patient with a history of prostate cancer, results of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT will be compared to pathology, clinical and follow-up result. Evaluation of the concordance between 68Ga-PSMA PET/MR and PET/CT, the differences between 68Ga-PSMA and 18F-FDG.
up to 2 years
Sensitivity of 68Ga-PSMA PET/MR, PET/CT for different PSA levels, different lesion sites
Time Frame: up to 2 years
For patient with a history of prostate cancer and suspected of recurrence, evaluate Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for different PSA levels, different lesion sites
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Investigators

  • Principal Investigator: Xiaoli Lan, MD, PhD, Wuhan Union Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 26, 2018

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

November 25, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (ACTUAL)

November 28, 2018

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XLan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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