- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05389202
Study of Prostate Perfusion Before Embolization in Patients With Symptomatic Prostate Adenoma (EMBOPERF)
Study of Prostate Perfusion Before Embolization in Patients With Symptomatic Prostate Adenoma. A Single-center Prospective Cohort Pilot Study to Determine the Predictive Factors of Clinical Efficacy Associated With a Prior Phantom Study.
Study Overview
Detailed Description
The hypothesis is that there are two types of prostate vascularization in patients with symptomatic prostate adenoma:
- prostates mainly vascularized by large caliber prostate arteries with high flow, for which perfusion parameters in favor of hyper-perfusion will be found. In this case, prostate artery embolization will be effective;
- prostates vascularized by a network of collaterals, with low flow-rates, for which perfusion parameters in favor of hypo-perfusion will be found. In this case, prostate artery embolization will not be very effective.
The purpose of this study is to investigate the association between prostate perfusion parameters (peak time, transit time, blood volume, capillary permeability) and the clinical efficacy of prostate embolization at 3 months. These perfusion parameters could become new biomarkers leading to better selection of patients eligible for efficient prostate embolization, in order to avoid a considerable treatment with no benefit for certain patients and thus limit their global exposure to X-rays during care.
Prior to this prospective study on patients with symptomatic benign prostate hypertrophy, a preliminary experimental study will be performed on a perfusion phantom in order to better understand the differences in the calculation of perfusion parameters according to the three main algorithms used. This will lead to optimization of the prostate perfusion protocol for the scanner: computed tomography acquisition parameters (kilovoltage, Milliamps per second) and therefore the X-ray dose delivered to patients, sampling frequency, and model to be used. The first results of this study have already led to modifications in scanner perfusion acquisition protocols for the initiation of clinical study.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julien FRANDON, Dr.
- Phone Number: +334 66 68 33 10
- Email: julien.frandon@chu-nimes.fr
Study Locations
-
-
Gard
-
Nîmes, Gard, France, 30029
- Recruiting
- Nîmes University Hospital
-
Contact:
- Julien FRANDON, Dr.
- Phone Number: +33466683310
- Email: julien.frandon@chu-nimes.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with symptomatic benign prostatic hypertrophy (prostate volume > 50, IPSS >7, QoL>2) or patients catheterized after acute retention of urine with failed catheterization.
- Creatinine clearance > 30 mL/min for one of the two Cockcroft-Gault/MDRD equations)
- Adult patients (≥18 years).
- Patients with an indication for prostate embolization.
- Patient with free and informed consent.
- Patient who have signed the consent form.
- Patient affiliated or beneficiary of a health insurance plan.
Exclusion Criteria:
- Hypersensitivity to the active substance or to one of the excipients of the iodized contrast medium.
- Severe renal impairment with renal function <30mL/min.
- Contraindication to prostate embolization (aorto-iliac bypass)
- Patient participating in research defined as Category 1 Research Involving Human Subjects.
- Patient in an exclusion period as determined by another study.
- Patient under court protection, guardianship or curatorship.
- Patient unable to give consent.
- Patient for whom it is impossible to give informed information.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients benefitting from a perfusion CT scan before embolization
Prostatic perfusion parameters seem to be correlated with the effectiveness of embolization.
Studying these prostatic perfusion parameters in perfusion CT and evaluating the prostatic Iodine load in dual energy CT will make it possible to better select responder patients.
|
Abdominopelvic CT scan with perfusion and spectral analysis performed 7 days (± 5 days) before prostate embolization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Catheterized patients: Removal of the urinary catheter at 3 months
Time Frame: Month 3
|
Yes/No
|
Month 3
|
Non-catheterized patients: 25% decrease in the International Prostate Symptom Score
Time Frame: Month 3
|
Yes/No
|
Month 3
|
Non-catheterized patients: one point improvement in the Global Quality of Life Score.
Time Frame: Month 3
|
Yes/No
|
Month 3
|
MRI perfusion parameters : Capillary permeability
Time Frame: 7 - 14 days before embolization
|
Measured in mL.mL tissue-1.min-1
|
7 - 14 days before embolization
|
Scanner perfusion parameters : Capillary permeability
Time Frame: Day 0 (on the day of embolization)
|
Measured in mL.mL tissue-1.min-1
|
Day 0 (on the day of embolization)
|
MRI perfusion parameters : Extracellular volume
Time Frame: 7 - 14 days before embolization
|
Measured in mL.mL tissue-1
|
7 - 14 days before embolization
|
Scanner perfusion parameters : Extracellular volume
Time Frame: Day 0 (on the day of embolization)
|
Measured in mL.mL tissue-1
|
Day 0 (on the day of embolization)
|
MRI perfusion parameters : Blood volume
Time Frame: 7 - 14 days before embolization
|
Measured in mL.mL tissue-1
|
7 - 14 days before embolization
|
Scanner perfusion parameters : Blood volume
Time Frame: Day 0 (on the day of embolization)
|
Measured in mL.mL tissue-1
|
Day 0 (on the day of embolization)
|
MRI perfusion parameters : Maximum slope
Time Frame: 7 - 14 days before embolization
|
Measured in ml.min-1
|
7 - 14 days before embolization
|
Scanner perfusion parameters : Maximum slope
Time Frame: Day 0 (on the day of embolization)
|
Measured in ml.min-1
|
Day 0 (on the day of embolization)
|
MRI perfusion parameters : Time to peak
Time Frame: 7 - 14 days before embolization
|
Measured in seconds
|
7 - 14 days before embolization
|
MRI perfusion parameters : Time to peak
Time Frame: Day 0 (on the day of embolization)
|
Measured in seconds
|
Day 0 (on the day of embolization)
|
Scanner perfusion parameters : Prostate iodine load at 80 s.
Time Frame: 7 - 14 days before embolization
|
Measured in mgI.mg of prostate-1
|
7 - 14 days before embolization
|
MRI perfusion parameters : Prostate iodine load at 80 s.
Time Frame: Day 0 (on the day of embolization)
|
Measured in mgI.mg of prostate-1
|
Day 0 (on the day of embolization)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Influence of flow rate on the scanner algorithm
Time Frame: 1 - 15 days before embolization. Preliminary stage on phantom.
|
The influence of flow rate on the scanner algorithm will be measured on the perfusion phantom model in mL.min-1.
|
1 - 15 days before embolization. Preliminary stage on phantom.
|
A. Correspondence between MRI and scanner: Capillary permeability
Time Frame: 1 - 7 days before embolization
|
Measured in mL.mL tissue-1.min-1
|
1 - 7 days before embolization
|
A. Correspondence between MRI and scanner: Extracellular volume
Time Frame: 1 - 7 days before embolization
|
Measured in mL.mL tissue-1
|
1 - 7 days before embolization
|
A. Correspondence between MRI and scanner: Blood volume
Time Frame: 1 - 7 days before embolization
|
Measured in mL.mL tissue-1
|
1 - 7 days before embolization
|
A. Correspondence between MRI and scanner: Maximum slope
Time Frame: 1 - 7 days before embolization
|
Measured in mL.min-1
|
1 - 7 days before embolization
|
A. Correspondence between MRI and scanner: Time to peak
Time Frame: 1 - 7 days before embolization
|
Measured in seconds
|
1 - 7 days before embolization
|
A. Correspondence between MRI and scanner: 80-second iodine load
Time Frame: 1 - 7 days before embolization
|
Measured in mgl.mg of prostate-1
|
1 - 7 days before embolization
|
B. 4-D map Magnetic Resonance Imaging perfusion parameters : Volume of beads injected
Time Frame: At the time of embolization
|
Measured in mL
|
At the time of embolization
|
B. Scanner perfusion parameters : Volume of beads injected
Time Frame: At the time of embolization
|
Measured in mL
|
At the time of embolization
|
C. Influence of scanner acquisition parameters: kV
Time Frame: 1 to 15 days before embolization. Preliminary stage on phantom.
|
The influence of scanner acquisition parameters on the scanner algorithm will be measured on the the perfusion phantom model.
|
1 to 15 days before embolization. Preliminary stage on phantom.
|
C. Influence of scanner acquisition parameters: mAs
Time Frame: 1 to 15 days before embolization. Preliminary stage on phantom.
|
The influence of scanner acquisition parameters on the scanner algorithm will be measured on the the perfusion phantom model.
|
1 to 15 days before embolization. Preliminary stage on phantom.
|
C. Influence of scanner acquisition parameters: iterative reconstruction
Time Frame: 1 to 15 days before embolization. Preliminary stage on phantom.
|
The influence of scanner acquisition parameters on the scanner algorithm will be measured on the the perfusion phantom model.
|
1 to 15 days before embolization. Preliminary stage on phantom.
|
C. Blood volume
Time Frame: 1 to 15 days before embolization. Preliminary stage on phantom.
|
The perfusion parameter "blood volume" will be measured on the phantom in mL
|
1 to 15 days before embolization. Preliminary stage on phantom.
|
C. Maximum slope
Time Frame: 1 to 15 days before embolization. Preliminary stage on phantom.
|
The perfusion parameter "maximum slope" will be measured on the phantom in mL.min-1
|
1 to 15 days before embolization. Preliminary stage on phantom.
|
C. Time to peak
Time Frame: 1 to 15 days before embolization. Preliminary stage on phantom.
|
The perfusion parameter "time to peak" will be measured on the phantom in seconds
|
1 to 15 days before embolization. Preliminary stage on phantom.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age
Time Frame: Day 0
|
In years
|
Day 0
|
Weight
Time Frame: Day 0
|
In kilograms
|
Day 0
|
Height
Time Frame: Day 0
|
In centimeters
|
Day 0
|
Comorbidities
Time Frame: Day 0
|
All comorbidities such as cardiovascular condition, smoking etc., and diabetes will be recorded on the electronic patient file.
|
Day 0
|
Adverse events
Time Frame: Day 0
|
Any adverse events will be recorded: Allergy to contrast medium, urinary tract sepsis, persistent urinary tract infection, dysuria, severe hematuria, hemospermia, bladder ulceration/necrosis, rectal ulcer, rectal bleeding, severe radiation skin injury, acute urinary retention, pelvic-perineal pain, acute urinary retention, prostatitis, orchi-epididymitis, obstructive renal failure, chronic bladder retention, lithiasis, hypocontractile bladder.
Puncture site hematoma, artery dissection/vessel injury (dissection, perforation, rupture, occlusion, spasm), false aneurysm requiring intervention, arteriovenous fistula requiring intervention, angioplasty or stenting, hematoma/bleeding requiring transfusion or surgery, arterial embolism/thrombosis, need for revascularization by bypass surgery, infection.
Due to dual-energy CT with contrast injection: stochastic risk of X-ray exposure; risks related to non-ionic contrast injection: intolerance, nausea, vomiting, urticaria, anaphylactic shock.
|
Day 0
|
Adverse events
Time Frame: Day 7
|
Any adverse events will be recorded: Allergy to contrast medium, urinary tract sepsis, persistent urinary tract infection, dysuria, severe hematuria, hemospermia, bladder ulceration/necrosis, rectal ulcer, rectal bleeding, severe radiation skin injury, acute urinary retention, pelvic-perineal pain, acute urinary retention, prostatitis, orchi-epididymitis, obstructive renal failure, chronic bladder retention, lithiasis, hypocontractile bladder.
Puncture site hematoma, artery dissection/vessel injury (dissection, perforation, rupture, occlusion, spasm), false aneurysm requiring intervention, arteriovenous fistula requiring intervention, angioplasty or stenting, hematoma/bleeding requiring transfusion or surgery, arterial embolism/thrombosis, need for revascularization by bypass surgery, infection.
Due to dual-energy CT with contrast injection: stochastic risk of X-ray exposure; risks related to non-ionic contrast injection: intolerance, nausea, vomiting, urticaria, anaphylactic shock.
|
Day 7
|
Adverse events
Time Frame: Month 3
|
Any adverse events will be recorded: Allergy to contrast medium, urinary tract sepsis, persistent urinary tract infection, dysuria, severe hematuria, hemospermia, bladder ulceration/necrosis, rectal ulcer, rectal bleeding, severe radiation skin injury, acute urinary retention, pelvic-perineal pain, acute urinary retention, prostatitis, orchi-epididymitis, obstructive renal failure, chronic bladder retention, lithiasis, hypocontractile bladder.
Puncture site hematoma, artery dissection/vessel injury (dissection, perforation, rupture, occlusion, spasm), false aneurysm requiring intervention, arteriovenous fistula requiring intervention, angioplasty or stenting, hematoma/bleeding requiring transfusion or surgery, arterial embolism/thrombosis, need for revascularization by bypass surgery, infection.
Due to dual-energy CT with contrast injection: stochastic risk of X-ray exposure; risks related to non-ionic contrast injection: intolerance, nausea, vomiting, urticaria, anaphylactic shock.
|
Month 3
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIMAO/2021-1/JF-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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