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

Purpose

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 and with every chemotherapy cycle.

Condition
Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT(Positron Emission Tomography/Computed Tomography)

Resource links provided by NLM:

Genetics Home Reference related topics: ovarian cancer

MedlinePlus related topics: Ovarian Cancer

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer Fallopian Tube Cancer

U.S. FDA Resources

Further study details as provided by Turku University Hospital:

Primary Outcome Measures:

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). [ Time Frame: PET/CT, contrast-enhanced CT and surgical status and histopathological findings are compared 1 month after surgery ]
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.

Secondary Outcome Measures:

Neoadjuvant chemotherapy (NACT) response evaluation with PET/CT compared with contrast-enhanced CT after 3 cycles of chemotherapy [ Time Frame: Outcome measure: after interval debulking surgery, about 4 months ]
Fdg PET/CT and a contrast-enhanced CT are performed in a row at the time of diagnosis and repeated after 3 cycles of chemotherapy. Finding are compared with disease status in the interval debulking surgery evaluated by operator and histological specimen.
Serial measurement of HE4 (human epididymis protein 4) and CA125 (cancer antigen 125)during primary treatment of EOC (Epithelial ovarian cancer) [ Time Frame: From diagnosis until the end of EOC primary therapy, about 8 months ]
HE4 and CA125 are measured at the time of diagnosis, perioperatively, and at each chemotherapy cycle (6-9). Treatment outcome is evaluated with contrast-enhanced CT at the end of primary therapy. HE4 and CA125 are compared with each other in different treatment outcomes (complete response, partial response, stable disease and progression)
Response to first line treatment: evaluation with PET/CT [ Time Frame: PET/CT taken about 4 weeks after the last chemotherapy cycle ]
Treatment outcome measured with RECIST 1.1 and GCIG criteria is compared with PET/CT results. The prognostic role of persistent metabolic activity in PET/CT is evaluated.

Biospecimen Retention: Samples With DNA

tumour samples, whole blood and serum samples


Estimated Enrollment:	150
Study Start Date:	October 2009
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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
previous cancer

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276574

Locations


Finland
Turku University hospital
Turku, Finland, 20521

Sponsors and Collaborators

Turku University Hospital

Investigators


Study Director:	Seija Grénman, professor	Turku University hospital, Department of Obstetrics and Gynecology
Principal Investigator:	Johanna Hynninen, MD, PhD	Turku University hospital, Department of Obstetrics and Gynecology
Principal Investigator:	Tuulia Vallius, MD	Turku University hospital, Dep of Ob/gyn and Dep of oncology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hynninen J, Kemppainen J, Lavonius M, Virtanen J, Matomäki J, Oksa S, Carpén O, Grénman S, Seppänen 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, Grénman S, Carpén 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, Carpén O, Dean K, Seppänen M, Kemppainen J, Lavonius M, Lisinen I, Virtanen J, Grénman 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.


Responsible Party:	Turku University Hospital
ClinicalTrials.gov Identifier:	NCT01276574 History of Changes
Other Study ID Numbers:	53/180/2009
Study First Received:	September 1, 2010
Last Updated:	May 22, 2017

Keywords provided by Turku University Hospital:


PET/CT Ovarian cancer HE4

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on May 25, 2017

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