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Combination of 68Ga-PSMA PET Data With Magnetic Resonance Spectroscopy Data (MRS) for Evaluating Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET/MR scan
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

1.patients over the age of 18 with diagnosed prostate cancer at different stages of the disease.

Exclusion Criteria:

  1. Patients younger than 18 years
  2. contraindication to MRI or to intravenous gadolinium injection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    prostate cancer Patients

    Arm Description

    patients over the age of 18 with diagnosed prostate cancer at different stages of the disease.

    Outcomes

    Primary Outcome Measures

    Patients who preformed 68Ga-PSMA for staging prostate cancer.
    Investigate implication of combining 68Ga-PSMA PET data and MRS data on staging and monitoring of prostate cancer

    Secondary Outcome Measures

    Full Information

    First Posted
    October 29, 2019
    Last Updated
    November 4, 2019
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04154280
    Brief Title
    Combination of 68Ga-PSMA PET Data With Magnetic Resonance Spectroscopy Data (MRS) for Evaluating Prostate Cancer
    Official Title
    Combination of 68Ga-PSMA PET Data With Magnetic Resonance Spectroscopy Data (MRS) for Evaluating Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 10, 2020 (Anticipated)
    Primary Completion Date
    May 10, 2021 (Anticipated)
    Study Completion Date
    April 10, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Prostate cancer is the second most common cancer among man and the fourth most occurring over all . Characterization and management of the diagnosed prostate cancer is a challenging task due to its clinically and morphologically diversity. Clinically, this cancer range from indolent growing slowly malignancy, which does not threatened the patient life, to aggressive tumor that metastasize rapidly with very bad prognosis. Therapy of prostate cancer ranges from a "watch and wait" approach to hormone deprivation therapy to aggressive surgical, radiation, and cryosurgical therapies depending on the cancer characteristics. Prostate cancer is diagnosed using digital rectal examination, serum prostate-specific antigen (PSA) testing and transrectal ultrasonography (US)-guided biopsies . Imaging technologies have been adapted as a non-invasive method to obtain a comprehensive assessment of the disease. MRI is widely used and more specifically multiparameter MRI (mMRI) for detection, staging and tumor localization. mMRI uses multiphase modes including diffusion-weighted and dynamic contrast-enhanced imaging in addition to T2-weighted imaging to identify and classify cancer type . Magnetic Resonance Spectroscopy (MRS) is MRI technique that allow detection of tissue metabolic composition which is occasionally used to characterize prostate cancer, however is not used as a standard procedure. By suppression of water and fat signal, MRS sequence can detect relationship between lower concentration prostatic metabolites such as citrate, choline, creatine, and polyamines in the cell cytosol and in the extra cellular ducts. Other imaging modalities used to characterize prostate cancer include ultrasound (US), computerized tomography (CT), functional imaging like bone scanning (BS) and hybrid imaging like choline based positron emission tomography and CT (PET/CT). However all of these modalities show disappointing sensitivity .
    Detailed Description
    In recent years a new modality has emerged showing promising accuracy targeting the Prostate Specific Membrane Antigen (PSMA) which is significantly overexpressed in prostate tumor cells. By attaching radioactive isotope 68Ga to PSMA ligands, PET/CT molecular imaging can provide information regarding prostate cancer relapses and metastases with high contrast . Several recent studies showed the potential of 68Ga-PSMA PET in many application correlated with prostate cancer such as staging, identifying reoccurrence, guided biopsy and others . In the study, we wish to utilize the new hybrid PET/MR technology and combine 68Ga-PSMA PET studies with MRS information in order to explore correlation between the data obtained by both modalities and investigate the implication on the disease characteristics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    prostate cancer Patients
    Arm Type
    Experimental
    Arm Description
    patients over the age of 18 with diagnosed prostate cancer at different stages of the disease.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    PET/MR scan
    Intervention Description
    The PET will be performed with 68Ga-PSMA tracer. The 3 tesla magnet of the MRI will be used with sequence allowing MRS acquisition, additional sequences will include T2-weighted contrast and diffusion weighted contrast. Images will be analyzed visually and quantitatively. Quantitative analysis will include MR parameters such as DWI apparent diffusion coefficient (ADC) and PET quantitative metabolic data such as standard uptake values (SUV) or Ki (in case dynamic PET protocol will be applied). In addition, content relationship between metabolic entities detected will be extracted. Quantitative data will be correlated to clinical and pathological data to check accuracy, specificity and sensitivity.
    Primary Outcome Measure Information:
    Title
    Patients who preformed 68Ga-PSMA for staging prostate cancer.
    Description
    Investigate implication of combining 68Ga-PSMA PET data and MRS data on staging and monitoring of prostate cancer
    Time Frame
    1 year

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1.patients over the age of 18 with diagnosed prostate cancer at different stages of the disease. Exclusion Criteria: Patients younger than 18 years contraindication to MRI or to intravenous gadolinium injection.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Combination of 68Ga-PSMA PET Data With Magnetic Resonance Spectroscopy Data (MRS) for Evaluating Prostate Cancer

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