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

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ClinicalTrials.gov Identifier: NCT03756077
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaoli Lan, Wuhan Union Hospital, China

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.

Condition or disease Intervention/treatment
Prostate Cancer PET/MR PET/CT Diagnostic Test: 68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT

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
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of the Value of Hybrid PET/MR and PET/CT in Prostate Cancer
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Central China
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756077


Contacts
Contact: Xiaoli Lan, MD, PhD +86-13886193262 lxl730724@hotmail.com

Locations
China, Hubei
Xiaoli Lan Recruiting
Wuhan, Hubei, China, 430022
Contact: Xiaoli Lan    +86-13886193262    lxl730724@hotmail.com   
Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
Principal Investigator: Xiaoli Lan, MD, PhD Wuhan Union Hospital, China

Responsible Party: Xiaoli Lan, Director of the Department of nuclear medicine, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT03756077     History of Changes
Other Study ID Numbers: XLan
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action