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Clinical Trials/NCT03756077
NCT03756077
Recruiting
Not Applicable

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

Wuhan Union Hospital, China1 site in 1 country100 target enrollmentApril 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Wuhan Union Hospital, China
Enrollment
100
Locations
1
Primary Endpoint
Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for initial diagnosis and staging
Status
Recruiting
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 26, 2018
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Wuhan Union Hospital, China
Responsible Party
Principal Investigator
Principal Investigator

Xiaoli Lan

Director of the Department of nuclear medicine

Wuhan Union Hospital, China

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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 Sites (1)

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