Fondazione Policlinico Universitaro "A. Gemelli" IRCCS
Roma, 00168, Italy
NCT Number: NCT06541171
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.
Trial opening soon.
Get Notified18 year and older
Female
Observational
Roma, 00168, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 36 months
Optimal cytoreductive surgery rate
Time frame: 36 months
Percentage of Concordance between MRI results and CA125 variations
Time frame: 36 months
Percentage of Concordance between MRI results and CT findings
Time frame: 36 months
Progression-Free Survival and Overall Survival Rate
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
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
Acronym: FOFU
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