Clinical trial NCT01276574: Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT
Official title: Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT(positron Emission Tomography/computed Tomography)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Epithelial Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Keywords: PET/CT
Ovarian cancer
HE4
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2011-01-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical suspicion of advanced EOC referred to surgery to Turku University hospital.

Brief summary: The purpose of this study is to determine, whether there is clinical benefit of using fdg-PET/CT (F-18-fluorodeoxyglucose- positron emission tomography/computed tomography)compared to contrast-enhanced CT in primary treatment of advanced epithelial ovarian cancer (EOC)

* 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


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patients with advanced epithelial ovarian, primary peritoneal cancer or fallopian tube cancer.
* age 18-79 years
* informed concent

Exclusion Criteria:

* diabetes (for PET/CT analyses)
* previous cancer

Primary outcomes:
measure: PET/CT (positron emission tomography/computed tomography)compared with contrast-enhanced CT in preoperative evaluation of disease burden in patients with advanced Epithelial ovarian cancer (EOC).
timeFrame: PET/CT, contrast-enhanced CT and surgical status and histopathological findings are compared 1 month after surgery
Secondary outcomes:
measure: Neoadjuvant chemotherapy (NACT) response evaluation with PET/CT compared with contrast-enhanced CT after 3 cycles of chemotherapy
timeFrame: Outcome measure: after interval debulking surgery, about 4 months
measure: Serial measurement of HE4 (human epididymis protein 4) and CA125 (cancer antigen 125)during primary treatment of EOC (Epithelial ovarian cancer)
timeFrame: From diagnosis until the end of EOC primary therapy, about 8 months
measure: Response to first line treatment: evaluation with PET/CT
timeFrame: PET/CT taken about 4 weeks after the last chemotherapy cycle
measure: HE4 and CA125 in 1st relapse
timeFrame: Long time follow up ad 10 years
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University hospital
Study officials:
affiliation: Turku University hospital, Department of Obstetrics and Gynecology
name: Johanna Hynninen, Adj prof
role: STUDY_DIRECTOR
affiliation: Turku University hospital, Department of Obstetrics and Gynecology
name: Johanna Hynninen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.