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MR-PET for Staging and Assessment of Operability in Ovarian Cancer - a Feasibility Study

Primary Purpose

Ovarian Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
MR-PET
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, Positron-Emission Tomography

Eligibility Criteria

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

Inclusion Criteria:

  • Expected FIGO stage IIB-IV epithelial ovarian carcinoma
  • Scheduled for primary debulking or interval debulking surgery
  • Written informed consent

Exclusion Criteria:

  • Patients estimated to have more benefit from chemotherapy
  • Ineligibility to undergo MR-PET examination (Non-MR compatible metallic implants or foreign bodies (ferromagnetic aneurysm clip, pacemaker, neurostimulation system, metal splinters etcetera) or claustrophobia)
  • Pregnant or lactating patients.
  • Incapacitated subjects

Sites / Locations

  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MR-PET

Arm Description

Preoperative whole-body MR-PET with 18F-FDG

Outcomes

Primary Outcome Measures

Diagnostic performance
Diagnostic performance of MR-PET compared to CT for characterisation of primary tumour, detection of tumour sites in the peritoneal cavity, retroperitoneum or liver, detection of lymphadenopathy and distant metastases and assessment of tumour stage and operability.

Secondary Outcome Measures

Full Information

First Posted
January 5, 2015
Last Updated
March 14, 2016
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02334371
Brief Title
MR-PET for Staging and Assessment of Operability in Ovarian Cancer - a Feasibility Study
Official Title
MR-PET for Staging and Assessment of Operability in Ovarian Cancer - a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The importance of selecting patients with ovarian cancer who will benefit from either primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to be discovered. We believe that combined magnetic resonance imaging and positron emission tomography (MR-PET) can be of great clinical value in preoperative staging of patients with ovarian cancer.
Detailed Description
Recently, the academic hospital Maastricht invested in an integrated MR-PET system (Biograph mMR, Siemens Healthcare, Erlangen, Germany), ready to use for routine clinical application. Applications of this system are numerous and various types of cancer, including ovarian cancer, could benefit from the possibilities. The whole-body MR-PET system integrates the strengths of MRI and PET within a single examination. MRI provides anatomic detail in staging local tumor extent due to its high soft tissue resolution and advanced functional techniques such as DWI further enhance both local and distant lesion detection and characterisation. PET imaging complements this structural and functional information with molecular imaging technology useful in staging of adenopathy and metastatic spread. These characteristics contribute to a wide spectrum of possible clinical oncological applications, from primary tumor detection to local and distant staging, selection of patients for neoadjuvant therapy and assessment of response to chemotherapy and finally evaluation of recurrent disease. The importance of selecting patients with ovarian cancer who will benefit from either primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to be discovered. We believe that combined magnetic resonance imaging and positron emission tomography (MR-PET) can be of great clinical value in preoperative staging of patients with ovarian cancer. Both positron emission tomography (PET), computed tomography (CT) and magnetic resonance imaging (MRI) have proved to be useful in ovarian cancer staging but understaging due to difficulties in depicting peritoneal dissemination remains a great problem. In conclusion, the best method for staging ovarian cancer and assessing operability remains to be discovered, hence this study.

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, Positron-Emission Tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MR-PET
Arm Type
Other
Arm Description
Preoperative whole-body MR-PET with 18F-FDG
Intervention Type
Radiation
Intervention Name(s)
MR-PET
Other Intervention Name(s)
MRI-PET, PET-MRI, PET-MR
Intervention Description
The MR-PET will be performed with the Biograph mMR system (Siemens Healthcare, Erlangen, Germany). This system integrates a 3Tesla MRI and PET scan which makes simultaneous acquisition of whole-body MRI and PET images possible. The Biograph mMR holds the CE mark and was FDA approved in June 2011. The Biograph mMR is intended to be used in the Academical hospita! Maastricht for standard patient care. The radiotracer that will be used is 18F-Iabeled fluorodeoxyglucose (18F-FDG), according to standard PET -protocol.
Primary Outcome Measure Information:
Title
Diagnostic performance
Description
Diagnostic performance of MR-PET compared to CT for characterisation of primary tumour, detection of tumour sites in the peritoneal cavity, retroperitoneum or liver, detection of lymphadenopathy and distant metastases and assessment of tumour stage and operability.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Expected FIGO stage IIB-IV epithelial ovarian carcinoma Scheduled for primary debulking or interval debulking surgery Written informed consent Exclusion Criteria: Patients estimated to have more benefit from chemotherapy Ineligibility to undergo MR-PET examination (Non-MR compatible metallic implants or foreign bodies (ferromagnetic aneurysm clip, pacemaker, neurostimulation system, metal splinters etcetera) or claustrophobia) Pregnant or lactating patients. Incapacitated subjects
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toon Van Gorp
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15661212
Citation
Qayyum A, Coakley FV, Westphalen AC, Hricak H, Okuno WT, Powell B. Role of CT and MR imaging in predicting optimal cytoreduction of newly diagnosed primary epithelial ovarian cancer. Gynecol Oncol. 2005 Feb;96(2):301-6. doi: 10.1016/j.ygyno.2004.06.054.
Results Reference
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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
20688446
Citation
De Iaco P, Musto A, Orazi L, Zamagni C, Rosati M, Allegri V, Cacciari N, Al-Nahhas A, Rubello D, Venturoli S, Fanti S. FDG-PET/CT in advanced ovarian cancer staging: value and pitfalls in detecting lesions in different abdominal and pelvic quadrants compared with laparoscopy. Eur J Radiol. 2011 Nov;80(2):e98-103. doi: 10.1016/j.ejrad.2010.07.013. Epub 2010 Aug 4.
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
18485169
Citation
Booth SJ, Turnbull LW, Poole DR, Richmond I. The accurate staging of ovarian cancer using 3T magnetic resonance imaging--a realistic option. BJOG. 2008 Jun;115(7):894-901. doi: 10.1111/j.1471-0528.2008.01716.x.
Results Reference
background
PubMed Identifier
17701040
Citation
Fujii S, Matsusue E, Kanasaki Y, Kanamori Y, Nakanishi J, Sugihara S, Kigawa J, Terakawa N, Ogawa T. Detection of peritoneal dissemination in gynecological malignancy: evaluation by diffusion-weighted MR imaging. Eur Radiol. 2008 Jan;18(1):18-23. doi: 10.1007/s00330-007-0732-9. Epub 2007 Aug 14.
Results Reference
background
PubMed Identifier
24753986
Citation
Partovi S, Kohan A, Rubbert C, Vercher-Conejero JL, Gaeta C, Yuh R, Zipp L, Herrmann KA, Robbin MR, Lee Z, Muzic RF Jr, Faulhaber P, Ros PR. Clinical oncologic applications of PET/MRI: a new horizon. Am J Nucl Med Mol Imaging. 2014 Mar 20;4(2):202-12. eCollection 2014.
Results Reference
background
PubMed Identifier
24322510
Citation
Michielsen K, Vergote I, Op de Beeck K, Amant F, Leunen K, Moerman P, Deroose C, Souverijns G, Dymarkowski S, De Keyzer F, Vandecaveye V. Whole-body MRI with diffusion-weighted sequence for staging of patients with suspected ovarian cancer: a clinical feasibility study in comparison to CT and FDG-PET/CT. Eur Radiol. 2014 Apr;24(4):889-901. doi: 10.1007/s00330-013-3083-8. Epub 2013 Dec 11.
Results Reference
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MR-PET for Staging and Assessment of Operability in Ovarian Cancer - a Feasibility Study

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