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

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ClinicalTrials.gov Identifier: NCT01276574
Recruitment Status : Active, not recruiting
First Posted : January 13, 2011
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital

Study Description
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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

Condition or disease
Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
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)
Study Start Date : October 2009
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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). [ 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 :
  1. 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.

  2. 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) and PFS and OS

  3. 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.

  4. HE4 and CA125 in 1st relapse [ Time Frame: Long time follow up ad 10 years ]
    Prognostic value of HE4 and CA125 at 1st recurrence (defined with RECIST1.1. and GCIG criteria) is evaluated against post progression survival


Biospecimen Retention:   Samples With DNA
tumour samples, whole blood and serum samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
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 (for PET/CT analyses)
  • previous cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276574


Locations
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Finland
Turku University hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01276574    
Other Study ID Numbers: 53/180/2009
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Keywords provided by Turku University Hospital:
PET/CT
Ovarian cancer
HE4
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases