Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer

Contrast Enhanced Diffusion-weighted Magnetic Resonance Imaging for Detection of Pathologic Lymph Nodes in Ovarian Cancer - a Feasibility Study.

Sponsors

Lead Sponsor: Maastricht University Medical Center

Source Maastricht University Medical Center
Brief Summary

Advanced epithelial ovarian cancer has high morbidity and mortality. Patients presenting with advanced stage ovarian cancer often have cancer spread to regional lymph nodes. Imaging strategies to depict involved lymph nodes are currently not successful. The purpose of this study is to evaluate if magnetic resonance imaging (MRI) with gadofosveset trisodium contrast enhancement (GDF-MRI) and diffusion weighted imaging (DW-MRI) is able to identify involved lymph nodes in a preoperative setting. This could guide the surgeon during surgery to dissect lymph nodes which could lead to an optimal diagnosis/staging with the lowest possible morbidity. We want to determine the optimal imaging settings and feasibility of MRI for the detection of pathological lymph nodes in women with advanced (FIGO stage IIB-IV) ovarian cancer undergoing primary debulking surgery and compare this to conventional imaging with computer tomography (CT).

Overall Status Withdrawn
Start Date September 2014
Completion Date September 2014
Primary Completion Date September 2014
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Feasibility of MRI in depicting lymph nodes. One year
Secondary Outcome
Measure Time Frame
Diagnostic accuracy of MRI. One year
Condition
Intervention

Intervention Type: Drug

Intervention Name: Gadofosveset trisodium (Ablavar™ )

Arm Group Label: GDF-MRI

Intervention Type: Device

Intervention Name: MRI

Arm Group Label: GDF-MRI

Eligibility

Criteria:

Inclusion Criteria:

- Non-pregnant female

- Expected FIGO stage IIB-IV epithelial ovarian carcinoma

- Scheduled for primary debulking surgery

- Written informed consent

- At least 18 years of age.

Exclusion Criteria:

- Patients estimated to have more benefit from neoadjuvant chemotherapy

- Ineligibility to undergo MRI

- Non-MR compatible metallic implants or foreign bodies (ferromagnetic aneurysm clip, pacemaker, neurostimulation system, etcetera).

- Claustrophobia

- Ineligibility to receive gadofosveset contrast (history of contrast allergy,

- History of a prior allergic reaction to the active substance or to any of the excipients of Ablavar™.

- Impaired kidney function (Glomerular Filtration Rate <30 ml/min/1.73m2).

- Previous para-aortic or pelvic lymphadenectomy

- History of a malignant tumour.

- Pregnant or lactating patients. Incapacitated subjects

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Toon Van Gorp, Dr Principal Investigator University Hospital Maastricht / GROW
Location
Facility: University Hospital Maastricht
Location Countries

Netherlands

Verification Date

September 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: GDF-MRI

Type: Experimental

Description: In this pilot study, all included patients will undergo conventional MRI with contrast enhancement (gadofosveset trisodium) and diffusion weighted MRI. Ablavar™ solution contains 244 mg/mL (0.25 mmol/mL) gadofosveset trisodium. 0.03 mmol/kg of gadofosveset will be administered by manual injection as a single intravenous bolus injection over a period of time up to 30 seconds followed by a 25-30 ml saline flush. In practice, this comes down to the maximum of one vial for one patient (one vial contains 10 ml solution, which contains a total of 2.50 mmol of gadofosveset trisodium equivalent to 2.27 g of gadofosveset).

Acronym MILO
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov