Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT
NCT ID: NCT01276574
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
150 participants
OBSERVATIONAL
2009-10-31
2024-12-31
Brief Summary
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* Objectives
* the impact of preoperative PET/CT compared to CT on EOC stage definition
* to compare the value of preoperative PET/CT, CT and laparoscopy in intra-abdominal tumour assessment. Laparotomy findings evaluated by surgeon and histopathologic results serve as the reference standard.
* to compare serum markers HE4(human epididymis protein 4) and CA125 (cancer antigen 125) with FDG-PET/CT and CT in treatment response evaluation during neoadjuvant chemotherapy and primary treatment of EOC
* to compare FDG PET/CT based treatment response evaluation with RECIST and GCIG criteria
* Methods
* All the patients will undergo FDG-PET/CT prior surgery, after possible neoadjuvant chemotherapy (NACT) and 4 weeks after completion of primary platinum-based chemotherapy.
* CA125 and HE4 levels are measured pre-operatively, with every chemotherapy cycle and regularly during follow-up until 1st disease relapse
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* age 18-79 years
* informed concent
Exclusion Criteria
* previous cancer
18 Years
79 Years
FEMALE
No
Sponsors
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Turku University Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Johanna Hynninen, Adj prof
Role: STUDY_DIRECTOR
Turku University hospital, Department of Obstetrics and Gynecology
Johanna Hynninen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Turku University hospital, Department of Obstetrics and Gynecology
Locations
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Turku University hospital
Turku, , Finland
Countries
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References
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Salminen L, Gidwani K, Grenman S, Carpen O, Hietanen S, Pettersson K, Huhtinen K, Hynninen J. HE4 in the evaluation of tumor load and prognostic stratification of high grade serous ovarian carcinoma. Acta Oncol. 2020 Dec;59(12):1461-1468. doi: 10.1080/0284186X.2020.1827157. Epub 2020 Oct 8.
Laasik M, Kemppainen J, Auranen A, Hietanen S, Grenman S, Seppanen M, Hynninen J. Behavior of FDG-avid supradiaphragmatic lymph nodes in PET/CT throughout primary therapy in advanced serous epithelial ovarian cancer: a prospective study. Cancer Imaging. 2019 May 29;19(1):27. doi: 10.1186/s40644-019-0215-7.
Hynninen J, Kemppainen J, Lavonius M, Virtanen J, Matomaki J, Oksa S, Carpen O, Grenman S, Seppanen M, Auranen A. A prospective comparison of integrated FDG-PET/contrast-enhanced CT and contrast-enhanced CT for pretreatment imaging of advanced epithelial ovarian cancer. Gynecol Oncol. 2013 Nov;131(2):389-94. doi: 10.1016/j.ygyno.2013.08.023. Epub 2013 Aug 29.
Hynninen J, Lavonius M, Oksa S, Grenman S, Carpen O, Auranen A. Is perioperative visual estimation of intra-abdominal tumor spread reliable in ovarian cancer surgery after neoadjuvant chemotherapy? Gynecol Oncol. 2013 Feb;128(2):229-32. doi: 10.1016/j.ygyno.2012.11.007. Epub 2012 Nov 9.
Hynninen J, Auranen A, Carpen O, Dean K, Seppanen M, Kemppainen J, Lavonius M, Lisinen I, Virtanen J, Grenman S. FDG PET/CT in staging of advanced epithelial ovarian cancer: frequency of supradiaphragmatic lymph node metastasis challenges the traditional pattern of disease spread. Gynecol Oncol. 2012 Jul;126(1):64-8. doi: 10.1016/j.ygyno.2012.04.023. Epub 2012 Apr 24.
Other Identifiers
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53/180/2009
Identifier Type: -
Identifier Source: org_study_id