Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541171
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
A New Fast DWI-based MR Protocol for Surveillance in Patients With a High Risk of Ovarian Cancer Recurrence During PARP-inhibitors Maintenance to Enhance Secondary Cytoreduction Results
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A New Fast DWI-based Magnetic Resonance Protocol for Surveillance in Patients With a High Risk of Ovarian Cancer Recurrence During PARP-inhibitors Maintenance to Enhance Secondary Cytoreduction Results
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOFU
Brief Summary:
In ovarian cancer OC complete surgical debulking and platinum-based chemotherapy are the standard treatment now followed by maintenance therapy with PARP inhibitors or Bevacizumab However in advanced-stage ovarian cancer recurrence is common with a progression-free survival of about 16 months Secondary cytoreductive surgery SCS at the time of recurrence prolongs the overall survival and gives the possibility to extend the use of PARP-i SCS is possible only when recurrence has limited extension However in OC there is no well-established and widely accepted scheme for surveillance during maintenance therapy ESMO guidelines suggest physical examination for the follow-up and allow ultrasound CT PET-CT and MRI to confirm the recurrence and plan surgical treatment if appropriate
Detailed Description:
Patients with OC in surveillance after first-line treatment usually have a scheme of clinical visits and serum marker evaluation every three months associated with alternated transvaginal ultrasound and chest abdomen and pelvis CT with contrast every three months and MRI with a confirmatory role in some cases
We will use an abbreviated MR protocol of the abdomen the most common location of relapse and the only one that can be treated by surgery in association with CT The abbreviated protocol is based on axial b50 b600 and b900 DWI with three-dimensional coronal maximum intensity projection MIP reconstruction of b900 values ADC maps and axial single-shot T2-weighted sequences which will take less than 20 minutes This MRI protocol does not need contrast injection and does not add any risk for patients
Any positive findings will be discussed at the Multidisciplinary Tumour Board and secondary cytoreductive surgery will be evaluated Surgery outcome and subsequent clinical information secondary PFS and OS derived by normal clinical practise will be registered in a dedicated database
We will use an abbreviated MR protocol of the abdomen the most common location of relapse and the only one that can be treated by surgery in association with CT The abbreviated protocol is based on axial b50 b600 and b900 DWI with three-dimensional coronal maximum intensity projection MIP reconstruction of b900 values ADC maps and axial single-shot T2-weighted sequences which will take less than 20 minutes This MRI protocol does not need contrast injection and does not add any risk for patients
Any positive findings will be discussed at the Multidisciplinary Tumour Board and secondary cytoreductive surgery will be evaluated Surgery outcome and subsequent clinical information secondary PFS and OS derived by normal clinical practise will be registered in a dedicated database
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None