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

Primary Purpose

Ovarian Neoplasms

Status
Withdrawn
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Gadofosveset trisodium (Ablavar™ )
MRI
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Neoplasms focused on measuring Magnetic Resonance Imaging, Gadofosveset trisodium, Nodal imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University Hospital Maastricht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GDF-MRI

Arm 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).

Outcomes

Primary Outcome Measures

Feasibility of MRI in depicting lymph nodes.
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.

Secondary Outcome Measures

Diagnostic accuracy of MRI.
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.

Full Information

First Posted
September 16, 2014
Last Updated
September 24, 2015
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02243059
Brief Title
Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer
Acronym
MILO
Official Title
Contrast Enhanced Diffusion-weighted Magnetic Resonance Imaging for Detection of Pathologic Lymph Nodes in Ovarian Cancer - a Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Problems with availability of study medicine in clinical center
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms
Keywords
Magnetic Resonance Imaging, Gadofosveset trisodium, Nodal imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GDF-MRI
Arm Type
Experimental
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Gadofosveset trisodium (Ablavar™ )
Other Intervention Name(s)
Ablavar, MS-325
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Feasibility of MRI in depicting lymph nodes.
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Diagnostic accuracy of MRI.
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.
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toon Van Gorp, Dr
Organizational Affiliation
University Hospital Maastricht / GROW
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Maastricht
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
17321572
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.
Results Reference
background
PubMed Identifier
12892797
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.
Results Reference
background
PubMed Identifier
8166218
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.
Results Reference
background
PubMed Identifier
20686371
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.
Results Reference
background
PubMed Identifier
16940979
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.
Results Reference
background
PubMed Identifier
8756375
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.
Results Reference
background
PubMed Identifier
22375721
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.
Results Reference
background
PubMed Identifier
23345344
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. Erratum In: AJR Am J Roentgenol. 2013 May;200(5):1174.
Results Reference
background
PubMed Identifier
18581404
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.
Results Reference
background
PubMed Identifier
21264658
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.
Results Reference
background
PubMed Identifier
22302265
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.
Results Reference
background
PubMed Identifier
21239980
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.
Results Reference
background
PubMed Identifier
23262788
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. Erratum In: Invest Radiol. 2013 May;48(5):332.
Results Reference
background

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Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer

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