Ovarian CarcinomaS53580NCT01657747
Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer
A study testing Whole body diffusion-weighted MRI in people with Ovarian Carcinoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim of this study is to assess whole body diffusion weighted imaging (WB-DWI) as a non-invasive method for accurate staging of patient suspected having ovarian cancer early treatment assessment detecting tumor recurrence Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- Whole body diffusion-weighted MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2011to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- STAGING: patients with suspected ovarian carcinoma
- EARLY TREATMENT ASSESSMENT: patients with FIGO stage IIIc or IV ovarian carcinoma who will undergo neoadjuvant chemotherapy
- IDENTIFYING TUMOR RECURRENCE: patients with a medical history of ovarian carcinoma with suspicion of recurrent ovarian cancer after a disease-free-interval of at least 6 months
Who cannot join
- patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients)will be excluded from this study.
- patients with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; GFR < 30 mL/min)and/or Buscopan
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospitals UZ Leuven, Gasthuisberg
Leuven, Leuven, 3000
About this study
The aim of this study is to assess whole body diffusion weighted imaging (WB-DWI) as a non-invasive method for
- accurate staging of patient suspected having ovarian cancer
- early treatment assessment
- detecting tumor recurrence
Read the detailed description
- Staging --- (PET-)CT is used nowadays to provide imaging information about the disease burden of ovarian cancer patients and a diagnostic staging laparoscopy under general anesthesia is often necessary to allow correct and accurate staging. The applicant propose an "all-in-one" imaging modality providing high quality thoracic-abdominal images without using ionizing radiation and/or radioactive material. This allows accurate assessment of operability in a minimally invasive manner.
- Early treatment assessment --- Although response to the first administration of chemotherapy is quite reasonable, most patients show tumor recurrence and achieve increasingly poorer response rates to second- or third-line regimes. Therefore it is of major concern that a individualized prediction of chemosensitivity can be performed avoiding unnecessary toxicity from inefficient chemotherapeutic agents. A promising perspective is that the predictive data to be generated might prove to be sufficiently powerful to predict chemosensitivity early in the course of the treatment, facilitating a timely change of treatment in nonresponders. This could avoid unnecessary toxicity for patients, improving quality of life and moreover implicate considerable savings for the healthcare sector.
- Identifying tumor recurrence --- Identifying tumor recurrence at an early stage could translate into reduction of unnecessary biopsies, cost savings and reduced morbidity associated with the biopsy procedure. But the most important issue is that early diagnosis can be life saving with respect to tumor recurrence.
- Conditions
- Ovarian Carcinoma
- Being tested
- Whole body diffusion-weighted MRI
- Keywords
- Ovarian carcinoma, Staging, Early treatment follow-up, Identifying tumor recurrence, Whole body diffusion-weighted MRI
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body diffusion-weighted MRIOther
Also called Dotarem, Buscopan
MRI is a technique based on magnetic fields and does not require the use of ionizing radiation. Although there are no known side effects associated with MRI, a few precautions should be taken because of the 3T magnetic field. This implicates that all metal and magnetized objects must be removed from the patient before entering the MRI room. Patients with a pacemaker, a cardiac defibrillator or other implanted conductors/prostheses are for this reason not eligible for the study.
During the whole body MRI examination, an intravenous contrast agent will be administered. In most cases, patients do not experience any discomfort and the use of this contrast agent is part of the clinical routine.
During the whole body MRI examinations, a bowel relaxing injection (Buscopan) is also needed to reduce movement of the intestines.
| Study group | Role | What they receive |
|---|---|---|
| Not applicable (imaging study) | No intervention | Not described Receives: Other: Whole body diffusion-weighted MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
Measured: Nov 2011 - Sep 2012 (up to 1 year)
WB-DWI for tumor characterization and staging at primary diagnosis
The aim of this part of the study is to prospectively evaluate WB-DWI for tumor characterization and staging at primary diagnosis in comparison to CT and combined CT/diagnostic laparoscopy with the aim to assess patient operability.
Measured: Nov 2011 - Nov 2015 (expected) (up to 4 years)
WB-DWI for response assessment during and early after neoadjuvant chemotherapy
The aim of this part of the study is to prospectively evaluate WB-DWI for (early) response assessment during and early after neoadjuvant chemotherapy in comparison to CT with the aim to predict chemotherapy induced tumor load regression and subsequent operability
Measured: Nov 2011 - Nov 2015 (expected) (up to 4 years)
Secondary outcomes (1)
The prognostic value of DWI-determined imaging markers
The aim of this part of the study is the determination of prognostic DWI-determined imaging and response markers towards patients disease free survival and overall survival.
Measured: Nov 2013 - Nov 2015 (expected) (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Vandecaveye, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657747
- Sponsor's protocol ID
- S53580
- Acronym
- S53580
- Status last verified
- Sep 2011
- First submitted
- 2 Nov 2011
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01657747
- Acronym / sponsor ID
- S53580 / S53580
- Conditions
- Ovarian Carcinoma
- Keywords
- Ovarian carcinoma, Staging, Early treatment follow-up, Identifying tumor recurrence, Whole body diffusion-weighted MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Aug 2012 (estimated)
- 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.
The aim of this study is to assess whole body diffusion weighted imaging (WB-DWI) as a non-invasive method for
- accurate staging of patient suspected having ovarian cancer
- early treatment assessment
- detecting tumor recurrence
Detailed description
- Staging --- (PET-)CT is used nowadays to provide imaging information about the disease burden of ovarian cancer patients and a diagnostic staging laparoscopy under general anesthesia is often necessary to allow correct and accurate staging. The applicant propose an "all-in-one" imaging modality providing high quality thoracic-abdominal images without using ionizing radiation and/or radioactive material. This allows accurate assessment of operability in a minimally invasive manner.
- Early treatment assessment --- Although response to the first administration of chemotherapy is quite reasonable, most patients show tumor recurrence and achieve increasingly poorer response rates to second- or third-line regimes. Therefore it is of major concern that a individualized prediction of chemosensitivity can be performed avoiding unnecessary toxicity from inefficient chemotherapeutic agents. A promising perspective is that the predictive data to be generated might prove to be sufficiently powerful to predict chemosensitivity early in the course of the treatment, facilitating a timely change of treatment in nonresponders. This could avoid unnecessary toxicity for patients, improving quality of life and moreover implicate considerable savings for the healthcare sector.
- Identifying tumor recurrence --- Identifying tumor recurrence at an early stage could translate into reduction of unnecessary biopsies, cost savings and reduced morbidity associated with the biopsy procedure. But the most important issue is that early diagnosis can be life saving with respect to tumor recurrence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Not applicable (imaging study) | No intervention | Other: Whole body diffusion-weighted MRI |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- STAGING: patients with suspected ovarian carcinoma
- EARLY TREATMENT ASSESSMENT: patients with FIGO stage IIIc or IV ovarian carcinoma who will undergo neoadjuvant chemotherapy
- IDENTIFYING TUMOR RECURRENCE: patients with a medical history of ovarian carcinoma with suspicion of recurrent ovarian cancer after a disease-free-interval of at least 6 months
Key exclusion criteria (2 listed)
- patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients)will be excluded from this study.
- patients with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; GFR < 30 mL/min)and/or Buscopan
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 |
|---|---|---|
| Whole body diffusion-weighted MRIAlso: Dotarem, BuscopanMRI is a technique based on magnetic fields and does not require the use of ionizing radiation. Although there are no known side effects associated with MRI, a few precautions should be taken because of the 3T magnetic field. This implicates that all metal and magnetized objects must be removed from the patient before entering the MRI room. Patients with a pacemaker, a cardiac defibrillator or other implanted conductors/prostheses are for this reason not eligible for the study. During the whole body MRI examination, an intravenous contrast agent will be administered. In most cases, patients do not experience any discomfort and the use of this contrast agent is part of the clinical routine. During the whole body MRI examinations, a bowel relaxing injection (Buscopan) is also needed to reduce movement of the intestines. | Other | Not applicable (imaging study) |
Primary outcome
Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
Time frame: Nov 2011 - Sep 2012 (up to 1 year)
Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
WB-DWI for tumor characterization and staging at primary diagnosis
Time frame: Nov 2011 - Nov 2015 (expected) (up to 4 years)
The aim of this part of the study is to prospectively evaluate WB-DWI for tumor characterization and staging at primary diagnosis in comparison to CT and combined CT/diagnostic laparoscopy with the aim to assess patient operability.
WB-DWI for response assessment during and early after neoadjuvant chemotherapy
Time frame: Nov 2011 - Nov 2015 (expected) (up to 4 years)
The aim of this part of the study is to prospectively evaluate WB-DWI for (early) response assessment during and early after neoadjuvant chemotherapy in comparison to CT with the aim to predict chemotherapy induced tumor load regression and subsequent operability
1 secondary outcome
The prognostic value of DWI-determined imaging markers
Time frame: Nov 2013 - Nov 2015 (expected) (up to 2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
Related trials for Ovarian Carcinoma
RecruitingPhase 2
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
Endocrine Tumors, Non-Small Cell Lung Cancer
RecruitingPhase 2
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
Epithelial Ovarian Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2
A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
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. This study is not recruiting at the moment.
Vincent Vandecaveye, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body diffusion-weighted MRI in people with Ovarian Carcinoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 2 Jul 2015. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study (time frame: Nov 2011 - Sep 2012 (up to 1 year)). The study lists 3 primary outcomes in all. 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 2 Jul 2015; AzTrials last refreshed its copy on 31 Oct 2026.