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

NCT03756077 | Unknown

• 1 other identifier: XLan
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; PET/MR; PET/CT

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for initial diagnosis and staging

  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 Outcomes (2)

• Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for recurrence detection

  up to 2 years

• Sensitivity of 68Ga-PSMA PET/MR, PET/CT for different PSA levels, different lesion sites

  up to 2 years

Study Arms (2)

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

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

Interventions

68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT DIAGNOSTIC_TEST

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; Primary diagnosis and staging

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Central China

You may qualify if:

• Patients suspected of or diagnosed with prostate cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Xiaoli Lan

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (1)

• Qin C, Gai Y, Liu Q, Ruan W, Liu F, Hu F, Zhang X, Lan X. Optimized Application of 68Ga-Prostate-Specific Membrane Antigen-617 Whole-Body PET/CT and Pelvic PET/MR in Prostate Cancer Initial Diagnosis and Staging. Front Med (Lausanne). 2021 May 13;8:657619. doi: 10.3389/fmed.2021.657619. eCollection 2021.

  PMID: 34055836 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Xiaoli Lan, MD, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoli Lan, MD, PhD

CONTACT

+86-13886193262; lxl730724@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of nuclear medicine

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 28, 2018
• Study Start: April 26, 2018
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

CN (1)