Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer (MILO)

Maastricht University Medical Centre (MUMC)

Status and phase: Withdrawn; Phase 4

Conditions: Ovarian Neoplasms

Treatments: Device: MRI; Drug: Gadofosveset trisodium (Ablavar™ )

Study type: Interventional

Funder types: Other

Identifiers

NCT02243059

142030

Details and patient eligibility

About

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).

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

GDF-MRI

Experimental group

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).

Treatment:

Device: MRI

Drug: Gadofosveset trisodium (Ablavar™ )