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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03756077
Other study ID # XLan
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 26, 2018
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source Wuhan Union Hospital, China
Contact Xiaoli Lan, MD, PhD
Phone +86-13886193262
Email lxl730724@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender Male
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Xiaoli Lan Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for recurrence detection 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
Secondary Sensitivity of 68Ga-PSMA PET/MR, PET/CT for different PSA levels, different lesion sites 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
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