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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

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06541171
Acronym
FOFU
Enrollment
220
Registered
2024-08-07
Start date
2024-09-01
Completion date
2027-08-31
Last updated
2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Recurrent Ovarian Carcinoma

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.

Interventions

OTHERMagnetic resonance imaging as fpr clinical practice

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.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cytoreductive surgery rate36 monthsOptimal cytoreductive surgery rate

Secondary

MeasureTime frameDescription
Concordance rate between MRI results and CA125 variations36 monthsPercentage of Concordance between MRI results and CA125 variations
Concordance between MRI results and CT findings36 monthsPercentage of Concordance between MRI results and CT findings
Rate of Survival36 monthsProgression-Free Survival and Overall Survival Rate

Countries

Italy

Contacts

Primary ContactGiacomo Avesani
giacomo.avesani@policlinicogemelli.it+390630156054

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026