Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer

NCT01657747 | Completed

• 1 other identifier: S53580
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ovarian Carcinoma

Keywords

Ovarian carcinoma; Staging; Early treatment follow-up; Identifying tumor recurrence; Whole body diffusion-weighted MRI

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  Nov 2011 - Nov 2015 (expected) (up to 4 years)

Secondary Outcomes (1)

• The prognostic value of DWI-determined imaging markers

  Nov 2013 - Nov 2015 (expected) (up to 2 years)

Study Arms (1)

Not applicable (imaging study)

NO INTERVENTION

Other: Whole body diffusion-weighted MRI

Interventions

Whole body diffusion-weighted MRI OTHER

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.

Also known as: Dotarem, Buscopan

Not applicable (imaging study)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals UZ Leuven, Gasthuisberg

Leuven, Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

gadoterate meglumine; Butylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Vincent Vandecaveye, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: August 6, 2012
• Study Start: November 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 2, 2015

Record last verified: 2011-09

Locations

BE (1)