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

NCT ID: NCT03756077

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-26

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer PET/MR PET/CT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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

Intervention Type 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

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

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

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Xiaoli Lan

Director of the Department of nuclear medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoli Lan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Xiaoli Lan

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoli Lan, MD, PhD

Role: CONTACT

+86-13886193262

Facility Contacts

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Xiaoli Lan

Role: primary

+86-13886193262

References

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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.

Reference Type DERIVED
PMID: 34055836 (View on PubMed)

Other Identifiers

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XLan

Identifier Type: -

Identifier Source: org_study_id

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