NCT00946140

Brief Summary

The purpose of this study is to develop new image analysis method using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) for ovarian cancer. MRI is not currently part of the standard care for ovarian cancer. In this method, a contrast agent is used to make ovarian cancer visible during imaging.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 24, 2013

Status Verified

October 1, 2013

Enrollment Period

4.3 years

First QC Date

July 23, 2009

Last Update Submit

October 23, 2013

Conditions

Ovarian Cancer

Keywords

OvaryMRI08-132

Outcome Measures

Primary Outcomes (1)

  • Development of automated motion correction algorithms and new functional methods that permit use of DCE-MRI in primary or metastatic tumors of the ovaries.

    2 years

Secondary Outcomes (1)

  • Testing of new methods using the DCE-MRI data sets for comparing changes in tumor perfusion with and without motion correction post anti-angiogenic therapy in ovarian cancer.

    2 years

Study Arms (1)

Patients with ovarian cancer currently undergoing treatment

All of the patients will be treated per their treatment protocols by their physicians and they will be referred to this study for the DCE-MRI scans at baseline, within 24-48 hours of the start of the therapy, and within 6-8 weeks of the start of the therapy.

Procedure: DCE-MRI scans

Interventions

DCE-MRI scansPROCEDURE

Initially you will be given safety information about MRI scans and a questionnaire to determine your compatibility with the MRI scanner. For each patient, DCE-MRI data sets will be acquired three times - at baseline just prior to the start of the drug therapy, within 24-48 hours of the start of the therapy, and within 6-8 weeks of the start of the therapy.

Patients with ovarian cancer currently undergoing treatment

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients will be recruited from the existing patient population at Gynecologic Medical Oncology Service at MSKCC. The patients meeting the eligibility criteria will be referred to DCE-MRI study by a physician in the GMO service at MSKCC.

You may qualify if:

  • Patients with measurable disease with evidence of at least one uni-dimensionally measurable tumor (\> 1 cm) by CT or MRI scan according to RECIST (Response Evaluation Criteria in Solid Tumors) that the tumor has not been initially treated with surgery or radiation therapy.
  • Patients who will start treatment with bevacizumab combined with or without cytotoxic chemotherapy within 14 days from signing consent. Patients treated on an approved IRB therapeutic protocol for recurrent ovarian cancer with bevacizumab are eligible.
  • Patients with histologically confirmed ovarian epithelial cancer including primary peritoneal and fallopian tube adenocarcinoma.
  • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception.
  • Patients who are older than 21 years of age.
  • Patients who are able to understand and sign informed consent.

You may not qualify if:

  • Patients treated on an approved IRB therapeutic protocol with a blinded arm of bevacizumab or placebo are not eligible (IRB 07-078 and IRB 05-138).
  • Patients with cardiac pacemakers.
  • Patients with certain prosthetic devices and implants who are not compatible with the high magnetic field present in the DCE-MRI scanners.
  • Patients who have experienced a prior adverse reaction to the gadolinium complex contrast agent used in DCE-MRI imaging and who don't meet criteria for creatinine and nephrogenic systemic sclerosis risk per guidelines of department of radiology.
  • Patients prone to claustrophobia.
  • Patients on dialysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • David Gultekin, Ph.D.

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 24, 2013

Record last verified: 2013-10

Locations

US(1)