Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT02243059
Status:
WITHDRAWN
Last Update Posted:
2015-09-28
First Post:
2014-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C109932', 'term': 'gadofosveset trisodium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Problems with availability of study medicine in clinical center', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-24', 'studyFirstSubmitDate': '2014-09-16', 'studyFirstSubmitQcDate': '2014-09-16', 'lastUpdatePostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic accuracy of MRI.', 'timeFrame': 'One year', 'description': 'Sensitivity, specificity, positive predictive value and negative predictive value for the detection of metastatic lymph nodes will be calculated for MRI (+/- DW-MRI and GDF-MRI) and compared with conventional CT imaging.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Magnetic Resonance Imaging', 'Gadofosveset trisodium', 'Nodal imaging'], 'conditions': ['Ovarian Neoplasms']}, 'referencesModule': {'references': [{'pmid': '17321572', 'type': 'BACKGROUND', 'citation': 'Pereira 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': '12892797', 'type': 'BACKGROUND', 'citation': 'Morice 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': '8166218', 'type': 'BACKGROUND', 'citation': 'Hoskins 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': '20686371', 'type': 'BACKGROUND', 'citation': 'Kim 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': '16940979', 'type': 'BACKGROUND', 'citation': "Maggioni 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': '8756375', 'type': 'BACKGROUND', 'citation': 'Onda 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.'}, {'pmid': '22375721', 'type': 'BACKGROUND', 'citation': 'Kumar Dhingra V, Kand P, Basu S. Impact of FDG-PET and -PET/CT imaging in the clinical decision-making of ovarian carcinoma: an evidence-based approach. Womens Health (Lond). 2012 Mar;8(2):191-203. doi: 10.2217/whe.11.91.'}, {'pmid': '23345344', 'type': 'BACKGROUND', 'citation': 'Wakefield JC, Downey K, Kyriazi S, deSouza NM. New MR techniques in gynecologic cancer. AJR Am J Roentgenol. 2013 Feb;200(2):249-60. doi: 10.2214/AJR.12.8932.'}, {'pmid': '18581404', 'type': 'BACKGROUND', 'citation': 'Lin G, Ho KC, Wang JJ, Ng KK, Wai YY, Chen YT, Chang CJ, Ng SH, Lai CH, Yen TC. Detection of lymph node metastasis in cervical and uterine cancers by diffusion-weighted magnetic resonance imaging at 3T. J Magn Reson Imaging. 2008 Jul;28(1):128-35. doi: 10.1002/jmri.21412.'}, {'pmid': '21264658', 'type': 'BACKGROUND', 'citation': 'Yamashita T, Takahara T, Kwee TC, Kawada S, Horie T, Inomoto C, Hashida K, Yamamuro H, Myojin K, Luijten PR, Imai Y. Diffusion magnetic resonance imaging with gadofosveset trisodium as a negative contrast agent for lymph node metastases assessment. Jpn J Radiol. 2011 Jan;29(1):25-32. doi: 10.1007/s11604-010-0513-2. Epub 2011 Jan 26.'}, {'pmid': '22302265', 'type': 'BACKGROUND', 'citation': 'Low RN, Barone RM. Combined diffusion-weighted and gadolinium-enhanced MRI can accurately predict the peritoneal cancer index preoperatively in patients being considered for cytoreductive surgical procedures. Ann Surg Oncol. 2012 May;19(5):1394-1401. doi: 10.1245/s10434-012-2236-3.'}, {'pmid': '21239980', 'type': 'BACKGROUND', 'citation': 'Lambregts DM, Beets GL, Maas M, Kessels AG, Bakers FC, Cappendijk VC, Engelen SM, Lahaye MJ, de Bruine AP, Lammering G, Leiner T, Verwoerd JL, Wildberger JE, Beets-Tan RG. Accuracy of gadofosveset-enhanced MRI for nodal staging and restaging in rectal cancer. Ann Surg. 2011 Mar;253(3):539-45. doi: 10.1097/SLA.0b013e31820b01f1.'}, {'pmid': '23262788', 'type': 'BACKGROUND', 'citation': 'Schipper RJ, Smidt ML, van Roozendaal LM, Castro CJ, de Vries B, Heuts EM, Keymeulen KB, Wildberger JE, Lobbes MB, Beets-Tan RG. Noninvasive nodal staging in patients with breast cancer using gadofosveset-enhanced magnetic resonance imaging: a feasibility study. Invest Radiol. 2013 Mar;48(3):134-9. doi: 10.1097/RLI.0b013e318277f056.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant female\n* Expected FIGO stage IIB-IV epithelial ovarian carcinoma\n* Scheduled for primary debulking surgery\n* Written informed consent\n* At least 18 years of age.\n\nExclusion Criteria:\n\n* Patients estimated to have more benefit from neoadjuvant chemotherapy\n* Ineligibility to undergo MRI\n\n * Non-MR compatible metallic implants or foreign bodies (ferromagnetic aneurysm clip, pacemaker, neurostimulation system, etcetera).\n * Claustrophobia\n* Ineligibility to receive gadofosveset contrast (history of contrast allergy,\n\n * History of a prior allergic reaction to the active substance or to any of the excipients of Ablavar™.\n * Impaired kidney function (Glomerular Filtration Rate \\<30 ml/min/1.73m2).\n* Previous para-aortic or pelvic lymphadenectomy\n* History of a malignant tumour.\n* Pregnant or lactating patients. Incapacitated subjects'}, 'identificationModule': {'nctId': 'NCT02243059', 'acronym': 'MILO', 'briefTitle': 'Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Contrast Enhanced Diffusion-weighted Magnetic Resonance Imaging for Detection of Pathologic Lymph Nodes in Ovarian Cancer - a Feasibility Study.', 'orgStudyIdInfo': {'id': '142030'}}, 'armsInterventionsModule': {'armGroups': [{'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.\n\nAblavar™ 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']}], 'interventions': [{'name': 'Gadofosveset trisodium (Ablavar™ )', 'type': 'DRUG', 'otherNames': ['Ablavar', 'MS-325'], 'armGroupLabels': ['GDF-MRI']}, {'name': 'MRI', 'type': 'DEVICE', 'armGroupLabels': ['GDF-MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'University Hospital Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Toon Van Gorp, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Maastricht / GROW'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}