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Trial 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
NCT ID:
NCT06541171
Condition:
Ovarian Cancer
Recurrent Ovarian Carcinoma
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Recurrence
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Magnetic resonance imaging as fpr clinical practice
Description:
An abbreviated MR protocol of the abdomen will be used inh association with CT scan; it
does not need contrast injection and does not add any risk for patients.
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.
Criteria for eligibility:
Study pop:
Patients with a diagnosis of HGSOC with BRCA wild-type, without residual tumour after
first debulking surgery, who are planned for CT/MRI exams as for Follow Up Clinical
Practice, after more than 6 months since the last platinum-based therapy
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients with BRCA wild-type, HRP, high-grade serous ovarian cancer
- No residual tumour at first debulking surgery
- More than 6 months since the last platinum-based therapy
Exclusion Criteria:
- Patients who will not consent to participate in the study
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitaro "A. Gemelli" IRCCS
Address:
City:
Roma
Zip:
00168
Country:
Italy
Start date:
September 1, 2024
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06541171
