Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Problems with availability of study medicine in clinical center
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gadofosveset trisodium (Ablavar™ ) | Drug | — | UNRESOLVED |
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GDF-MRI
- 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).
- interventionNames
- Drug: Gadofosveset trisodium (Ablavar™ )
- Device: MRI
Primary outcomes (1)
- measure
- Feasibility of MRI in depicting lymph nodes.
- timeFrame
- One year
- description
- Primary outcome measure is to determine the optimal imaging settings and feasibility of MRI combined with DW-MRI and GDF-MRI (gadofosveset-MRI) in the identification of pathologic lymph nodes in women with advanced stage epithelial ovarian cancer.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDPereira A, Magrina JF, Rey V, Cortes M, Magtibay PM. Pelvic and aortic lymph node metastasis in epithelial ovarian cancer. Gynecol Oncol. 2007 Jun;105(3):604-8. doi: 10.1016/j.ygyno.2007.01.028. Epub 2007 Feb 23. PMID 17321572
- BACKGROUNDMorice P, Joulie F, Camatte S, Atallah D, Rouzier R, Pautier P, Pomel C, Lhomme C, Duvillard P, Castaigne D. Lymph node involvement in epithelial ovarian cancer: analysis of 276 pelvic and paraaortic lymphadenectomies and surgical implications. J Am Coll Surg. 2003 Aug;197(2):198-205. doi: 10.1016/S1072-7515(03)00234-5. PMID 12892797
- BACKGROUNDHoskins WJ, McGuire WP, Brady MF, Homesley HD, Creasman WT, Berman M, Ball H, Berek JS. The effect of diameter of largest residual disease on survival after primary cytoreductive surgery in patients with suboptimal residual epithelial ovarian carcinoma. Am J Obstet Gynecol. 1994 Apr;170(4):974-9; discussion 979-80. doi: 10.1016/s0002-9378(94)70090-7. PMID 8166218
- BACKGROUNDKim HS, Ju W, Jee BC, Kim YB, Park NH, Song YS, Kim SC, Kang SB, Kim JW. Systematic lymphadenectomy for survival in epithelial ovarian cancer: a meta-analysis. Int J Gynecol Cancer. 2010 May;20(4):520-8. doi: 10.1111/IGC.0b013e3181d6de1d. PMID 20686371
- BACKGROUNDMaggioni A, Benedetti Panici P, Dell'Anna T, Landoni F, Lissoni A, Pellegrino A, Rossi RS, Chiari S, Campagnutta E, Greggi S, Angioli R, Manci N, Calcagno M, Scambia G, Fossati R, Floriani I, Torri V, Grassi R, Mangioni C. Randomised study of systematic lymphadenectomy in patients with epithelial ovarian cancer macroscopically confined to the pelvis. Br J Cancer. 2006 Sep 18;95(6):699-704. doi: 10.1038/sj.bjc.6603323. Epub 2006 Aug 29. PMID 16940979
- BACKGROUNDOnda T, Yoshikawa H, Yokota H, Yasugi T, Taketani Y. Assessment of metastases to aortic and pelvic lymph nodes in epithelial ovarian carcinoma. A proposal for essential sites for lymph node biopsy. Cancer. 1996 Aug 15;78(4):803-8. doi: 10.1002/(SICI)1097-0142(19960815)78:43.0.CO;2-Z.