Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT

NCT01276574 | Active Not Recruiting

• 1 other identifier: 53/180/2009
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Keywords

PET/CT; Ovarian cancer; HE4

Outcome Measures

Primary Outcomes (1)

• 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).

  Patient is scanned with whole body Fdg PET/CT and contrast-enhanced CT in a row within 3 weeks preoperatively. Findings are compared with intraoperative surgical status evaluated by operator and confirmed with biopsies.

  PET/CT, contrast-enhanced CT and surgical status and histopathological findings are compared 1 month after surgery

Secondary Outcomes (4)

• Neoadjuvant chemotherapy (NACT) response evaluation with PET/CT compared with contrast-enhanced CT after 3 cycles of chemotherapy

  Outcome measure: after interval debulking surgery, about 4 months

• Serial measurement of HE4 (human epididymis protein 4) and CA125 (cancer antigen 125)during primary treatment of EOC (Epithelial ovarian cancer)

  From diagnosis until the end of EOC primary therapy, about 8 months

• Response to first line treatment: evaluation with PET/CT

  PET/CT taken about 4 weeks after the last chemotherapy cycle

• HE4 and CA125 in 1st relapse

  Long time follow up ad 10 years

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical suspicion of advanced EOC referred to surgery to Turku University hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University hospital

Turku, 20521, Finland

Location

Related Publications (5)

• 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.

  PMID: 33030975 DERIVED

• 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.

  PMID: 31142357 DERIVED

• 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.

  PMID: 23994535 DERIVED

• 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.

  PMID: 23142076 DERIVED

• 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.

  PMID: 22542580 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

tumour samples, whole blood and serum samples

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Johanna Hynninen, Adj prof

  Turku University hospital, Department of Obstetrics and Gynecology

  STUDY DIRECTOR

• Johanna Hynninen, MD, PhD

  Turku University hospital, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: January 13, 2011
• Study Start: October 1, 2009
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

FI (1)