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Epithelial Ovarian CancerMupetNCT01276574

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

An observational study of Epithelial Ovarian Cancer and Peritoneal Cancer, run by Turku University Hospital at 1 site in Finland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 79 years, women only
How many people
150 participants
Where
1 siteFinland
Study dates
Oct 2009to 31 Dec 2024
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Turku University hospital

    Turku, 20521

Other trials in Finland

About this study

Official title: Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT(positron Emission Tomography/computed Tomography)

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
Keywords
PET/CT, Ovarian cancer, HE4
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

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

    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.

    Measured: Outcome measure: after interval debulking surgery, about 4 months

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

    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

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

  3. Response to first line treatment: evaluation with PET/CT

    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.

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

  4. HE4 and CA125 in 1st relapse

    Prognostic value of HE4 and CA125 at 1st recurrence (defined with RECIST1.1. and GCIG criteria) is evaluated against post progression survival

    Measured: Long time follow up ad 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2011 (estimated)
  2. Study startOct 2009
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01276574
Sponsor's protocol ID
53/180/2009
Acronym
Mupet
Status last verified
Dec 2024
First submitted
1 Sep 2010
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No

Publications

  • Peippo MH, Perkonoja K, Isoviita VM, Hynninen J, Lassila R, Carpen O. Association of clinical and laboratory variables with risk of venous thromboembolism in high-grade serous ovarian cancer. Int J Gynecol Cancer. 2025 Feb;35(2):100019. doi: 10.1016/j.ijgc.2024.100019. Epub 2024 Dec 17.

    PubMed 39971419

  • 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.

    PubMed 33030975

  • 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.

    PubMed 31142357

  • 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.

    PubMed 23994535

  • 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.

    PubMed 23142076

  • 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.

    PubMed 22542580

Questions about this trial

What is this clinical trial studying?

An observational study of Epithelial Ovarian Cancer and Peritoneal Cancer, run by Turku University Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). (time frame: PET/CT, contrast-enhanced CT and surgical status and histopathological findings are compared 1 month after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01276574, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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