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
About this trial
This is an interventional diagnostic trial for Prostate Cancer
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.
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
NCT ID
NCT04154280
First Posted
October 29, 2019
Last Updated
November 4, 2019
Sponsor
Tel-Aviv Sourasky Medical Center
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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