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NCT Number: NCT06541171

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic resonance imaging as fpr clinical practice

Other

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.

Primary outcomes

  1. Cytoreductive surgery rate

    Time frame: 36 months

    Optimal cytoreductive surgery rate

Secondary outcomes

  1. Concordance rate between MRI results and CA125 variations

    Time frame: 36 months

    Percentage of Concordance between MRI results and CA125 variations

  2. Concordance between MRI results and CT findings

    Time frame: 36 months

    Percentage of Concordance between MRI results and CT findings

  3. Rate of Survival

    Time frame: 36 months

    Progression-Free Survival and Overall Survival Rate

Study contacts

Contact information is provided by the study sponsor or research team.

Giacomo Avesani

CONTACT

[email protected]

+390630156054

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study 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

Acronym: FOFU

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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