Ovarian CancerFOFUNCT06541171
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
An observational study of Ovarian Cancer and Recurrent Ovarian Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Recurrent Ovarian Carcinoma
- What is being tested?
- Magnetic resonance imaging as fpr clinical practice
- Type of treatment
- Injection or infusion
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- Patients who will not consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Ovarian Cancer, Recurrent Ovarian Carcinoma
- Being tested
- Magnetic resonance imaging as fpr clinical practice
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging as fpr clinical practiceOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytoreductive surgery rate
Optimal cytoreductive surgery rate
Measured: 36 months
Secondary outcomes (3)
Concordance rate between MRI results and CA125 variations
Percentage of Concordance between MRI results and CA125 variations
Measured: 36 months
Concordance between MRI results and CT findings
Percentage of Concordance between MRI results and CT findings
Measured: 36 months
Rate of Survival
Progression-Free Survival and Overall Survival Rate
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giacomo Avesani, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541171
- Sponsor's protocol ID
- 6887
- Acronym
- FOFU
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06541171
- Acronym / sponsor ID
- FOFU / 6887
- Conditions
- Ovarian Cancer, Recurrent Ovarian Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who will not consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging as fpr clinical practiceAn 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. | Other | – |
Primary outcome
Cytoreductive surgery rate
Time frame: 36 months
Optimal cytoreductive surgery rate
3 secondary outcomes
Concordance rate between MRI results and CA125 variations
Time frame: 36 months
Concordance between MRI results and CT findings
Time frame: 36 months
Rate of Survival
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
RecruitingPhase 3
A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
Ovarian Cancer, Ovarian Neoplasms
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
Not yet recruitingPhase 1
First-in-Human, Multicenter, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of YL-18319 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors
Solid Tumors, Ovarian
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giacomo Avesani principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Recurrent Ovarian Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giacomo Avesani (+390630156054, giacomo.avesani@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytoreductive surgery rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.