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Ovarian CancerNCT01242436

Whole Body Diffusion MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Ovarian Cancer and Peritoneal Metastasis

A study testing intravenous contrast administration in people with Ovarian Cancer and Peritoneal Metastasis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Ovarian cancer is a gynecological cancer with a high risk of mortality. This is because the diagnosis is often been made in an advanced cancer stage with metastases throughout the peritoneum. An international study led by Prof. Dr. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Ovarian Cancer, Peritoneal Metastasis
What is being tested?
intravenous contrast administration
How many people
50 participants
Where
1 siteBelgium
Study dates
Jan 2011to Dec 2014
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

  • Patients diagnosed with stage IIIC or IV epithelial ovarian cancer in the presence of peritoneal metastasis are, on a voluntary basis, enrolled in the study. These are patients who 'll either underwent primary debulking surgery followed by at least six courses of platinum-based chemotherapy or patients who will be assigned to three courses of neoadjuvant platinum-based chemotherapy followed by interval debulking surgery, followed in turn by at least three courses of platinum-based chemotherapy.

Who cannot join

  • Patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients) will be excluded from this study. And so are patients with contra-indications to Gadolinium-based contrast agents and patients with a known restricted renal function (GFR < 30 ml/min).

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • University Hospital Gasthuisberg

    Leuven, Leuven, 3000

Other trials in Belgium

About this study

Ovarian cancer is a gynecological cancer with a high risk of mortality. This is because the diagnosis is often been made in an advanced cancer stage with metastases throughout the peritoneum.

An international study led by Prof. Dr. Ignace Vergote (Gynaecological Oncology) showed for the first time that patients in such an advanced stage of ovarian cancer who received first three neoadjuvant platinum-based chemotherapy regimens followed by interval debulking surgery, and in turn followed by at least 3 treatment with platinum-based chemotherapy, had fewer complications than patients treated with primary debulking surgery followed by chemotherapy. Moreover, the final survival rate in both groups seemed to be similar. The most important prognostic marker appeared to be whether patients with primary or interval surgery no longer had a visible residual tumor after the treatment. Patients who had only small metastases in the peritoneum, seemed to be better treated with primary surgery (neoadjuvant Vergote I, et al Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Crystallising, N Engl J Med 363 (1910): 943 - 953).

Read more

Each patient with suspected advanced ovarian cancer should undergo a preoperative evaluation where they assess which of the two treatments is the best option.

The aim of the study is to assess whole body diffusion weighted imaging (WB-DWI) as a non-invasive method, in patients with confirmed ovarian cancer in the presence of peritoneal metastases. This is to assess which of the two treatments (primary debulking surgery followed chemotherapy versus platinum-based neoadjuvant chemotherapy followed by interval debulking surgery, followed in turn by chemotherapy) is the best option for a particular type of patient.

Read the detailed description

BACKGROUND OF THE STUDY

Ovarian cancer is a gynecological cancer with a high risk of mortality. This is because the diagnosis is often been made in an advanced cancer stage with metastases throughout the peritoneum. The standard treatment for this condition till now consisted of primary debulking surgery where the tumor, the uterus and both the ovaries were removed, followed by a minimum of six treatments with platinum-based chemotherapy. This operation is often accompanied by serious complications such as for example bleedings, embolic events, infections and in extreme cases, even mortality. An international study led by Prof. Dr. Ignace Vergote (Gynaecological Oncology) showed for the first time that patients in such an advanced stage of ovarian cancer who received first three neoadjuvant platinum-based chemotherapy regimens followed by interval debulking surgery, and in turn followed by at least 3 treatment with platinum-based chemotherapy, had fewer complications than patients treated with primary debulking surgery followed by chemotherapy. Moreover, the final survival rate in both groups seemed to be similar. The most important prognostic marker appeared to be whether patients with primary or interval surgery no longer had a visible residual tumor after the treatment. Patients who had only small metastases in the peritoneum, seemed to be better treated with primary surgery (neoadjuvant Vergote I, et al Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Crystallising, N Engl J Med 363 (1910): 943 - 953).

Each patient with suspected advanced ovarian cancer should undergo a preoperative evaluation where they assess which of the two treatments is the best option. This should of course, for each individual patient, take into account comorbidity, cancer stage, number and location of the metastases etc. Currently,[18F] FDG-PET/CT, CT and conventional MRI are being used for staging, detecting recurrence and metastasis and for evaluating therapy response. These techniques have some disadvantages. A PET study takes a long time to perform and makes use of radioactive material. The addition of CT also gives rise to additional radiation. [18F] FDG accumulates in inflammatory cells in the tumor. This can explain the difficulties concerning early evaluation of treatment response. Although CT allows high resolution images of the entire body, sometimes the technology lacks sufficient sensitivity or specificity. Although conventional MRI has the highest sensitivity for detection of liver metastases, the lack of efficient whole-body imaging for staging a disadvantage when assessing systemic tumor spread and metastasis. Small peritoneal metastases are therefore often missed with this technique.

Diffusion-weighted imaging (DWI) is an emerging technology that is currently being uses in cancer imaging. Here the difference in movement of water molecules provides information about the integrity of cellular membranes. DWI has the advantage that no contrast material is required and there is also no need for exposure to ionizing radiation. Further developments in technology allowed for an acceptable time in whole body conducting research, so we should be able to image gastrointestinal tumors with this whole body technique.

AIM OF THE STUDY

The aim of the study is to assess whole body diffusion weighted imaging (WB-DWI) as a non-invasive method, in patients with confirmed ovarian cancer in the presence of peritoneal metastases. This is to assess which of the two treatments (primary debulking surgery followed chemotherapy versus platinum-based neoadjuvant chemotherapy followed by interval debulking surgery, followed in turn by chemotherapy) is the best option for a particular type of patient.

Being tested
intravenous contrast administration
Keywords
Ovarian Cancer, Peritoneal Metastasis, Whole body diffusion MRI, therapy
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intravenous contrast administrationProcedure or surgery

    The additional burden is restricted to a WB-DWI scan before and during therapy.

    MRI is a technique based on magnetic fields and do not require the use of ionizing radiation. Because of the strong magnetic field, a few precautions should be taken. This means 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 conductor/prosthesis are for this reason not eligible for the study.

    During the examination, an intravenous 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of WB-DWI as a noninvasive method to assess which kind of treatment fits best for a particular patient with ovarian cancer in the presence of peritoneal metastasis

    The aim of the study is to assess whole body diffusion weighted imaging (WB-DWI)as a non-invasive method, in patients with confirmed ovarian cancer in the presence of peritoneal metastases. This is to evaluate which of the two treatments (primary debulking surgery followed chemotherapy versus platinum-based neoadjuvant chemotherapy followed by interval debulking surgery, followed in turn by chemotherapy) is the best option for a particular type of patient.

    Measured: 2011-2015 continuously

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2013
  4. Study completionDec 2014

Resources

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
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01242436
Sponsor's protocol ID
S52920
Status last verified
Apr 2015
First submitted
16 Nov 2010
Last updated
10 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing intravenous contrast administration in people with Ovarian Cancer and Peritoneal Metastasis, 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 1 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: finished, as of the sponsor's last update on 10 Apr 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?

Evaluation of WB-DWI as a noninvasive method to assess which kind of treatment fits best for a particular patient with ovarian cancer in the presence of peritoneal metastasis (time frame: 2011-2015 continuously). 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 10 Apr 2015.

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