MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imaging (MISOBOLD)
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
F-MISO PET imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, MRI, BOLD, 18F-MISO, PET
Eligibility Criteria
Inclusion Criteria:
- Patient above 18.
- Prostate tumor with histological confirmed diagnosis and highly radiological suspected target on MRI
- High risk patient : >T2c grade, Glasgow score > 7 and PSA > 20ng/ml
- Surgical treatment chosen during multidisciplinary meeting
- ECOG ≤2
- Patient must have undergone MRI with BOLD sequence less than 6 month prior surgery
- Member or beneficiary of a social security system.
- Signed informed consent.
Exclusion Criteria:
- Patient included in another clinical study
- Geographical, social or psychological reasons preventing patient from submitting to the study's medical monitoring
- Patient deprive of liberty, adult subjects to legal protection or unable to give consent
- Contraindications to MRI
- Contraindication to gadolinium injection
Sites / Locations
- Centre de Lutte Contre le Cancer
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
F-MISO PET imaging
Arm Description
F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.
Outcomes
Primary Outcome Measures
comparison between histological results and oxygenation quantitative values from MRI and PET exams
Correlation study between anatomopatology data, product by prostatectomy anatomic piece, using HIF1-CAIX histological markers and:
on one hand PET FMISO uptake
on the other hand, MRI BOLD signal
Secondary Outcome Measures
quantitative analysis
a quantitative analysis of inter-individual variability will be done in order o compare inter-individual variability of hypoxia measures between the two imaging modalities
Full Information
NCT ID
NCT03293602
First Posted
September 20, 2017
Last Updated
November 25, 2019
Sponsor
University Hospital, Bordeaux
Collaborators
Cancéropôle GSO and GIRCI SOOM (API-K)
1. Study Identification
Unique Protocol Identification Number
NCT03293602
Brief Title
MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imaging
Acronym
MISOBOLD
Official Title
MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imagin
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Withdrawn
Why Stopped
the team has changed. the new team did not have the perosnnel to set up the study
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Cancéropôle GSO and GIRCI SOOM (API-K)
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
This feasibility exploratory study objective is to assess the ability of combined MRI BOLD and 18F-MISO PET imaging to visualize tumor hypoxia compare to histological results obtained after radical prostatectomy in order to, in time, be able to identify patient with bad prognostic and to offer them the best therapeutic strategy.
Detailed Description
Prostate cancer is the fisrt one in male with 80.000 new cases each year in France. Forty thousand curative treatments are performed each year, but 25 to 30% of these patients will present a cancer reccurence after radical surgery or conformationnal radiotherapy, Tissu hypoxia seems to be mainly responsible of the local reccurence and conduct to molecular damages that creates carcinogenesis and tumor agressitivity. This hypoxia inhibits the DNA healing and the apoptosis but increases the angiogenesis, that leads to treatment resistance. L. Marignol &al clearly showed that hypoxia may have a main role in hormonal resistance. Furthermore, M. Milosevic & al showed that hypoxia is an independent factor of local reccurence after radiotherapy. Nowadays, new technics of IMRT in radiotherapy planning could be able to target an hypoxic prostate region to prevent reccurence. Patients who are eligible to radical prostatectomy will benefit of a prostate MRI with BOLD sequences and a 18F-misonidazole PET before surgery. The results of these two technics will be compared to the histological results using CAIX and HIF immunohistochemistery markers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, MRI, BOLD, 18F-MISO, PET
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F-MISO PET imaging
Arm Type
Experimental
Arm Description
F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.
Intervention Type
Device
Intervention Name(s)
F-MISO PET imaging
Intervention Description
F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.
Primary Outcome Measure Information:
Title
comparison between histological results and oxygenation quantitative values from MRI and PET exams
Description
Correlation study between anatomopatology data, product by prostatectomy anatomic piece, using HIF1-CAIX histological markers and:
on one hand PET FMISO uptake
on the other hand, MRI BOLD signal
Time Frame
Inclusion, 1 month
Secondary Outcome Measure Information:
Title
quantitative analysis
Description
a quantitative analysis of inter-individual variability will be done in order o compare inter-individual variability of hypoxia measures between the two imaging modalities
Time Frame
Inclusion, 1 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient above 18.
Prostate tumor with histological confirmed diagnosis and highly radiological suspected target on MRI
High risk patient : >T2c grade, Glasgow score > 7 and PSA > 20ng/ml
Surgical treatment chosen during multidisciplinary meeting
ECOG ≤2
Patient must have undergone MRI with BOLD sequence less than 6 month prior surgery
Member or beneficiary of a social security system.
Signed informed consent.
Exclusion Criteria:
Patient included in another clinical study
Geographical, social or psychological reasons preventing patient from submitting to the study's medical monitoring
Patient deprive of liberty, adult subjects to legal protection or unable to give consent
Contraindications to MRI
Contraindication to gadolinium injection
Facility Information:
Facility Name
Centre de Lutte Contre le Cancer
City
Toulouse
ZIP/Postal Code
31300
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imaging
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