NCT05855941

Brief Summary

The goal of this observational study is to learn about the added diagnostic and prognostic value of advanced medical imaging procedures in cervical cancer, endometrial cancer and ovarian cancer. The main questions it aims to answer are:

  • Does advanced medical imaging predict survival?
  • Can advanced medical imaging improve radiotherapy target planning?
  • Are advanced medical imaging results associated with risk markers found in tumor tissue? Participants will
  • Undergo four additional imaging procedures, as compared to clinical routine examinations, two at baseline and two after three months.
  • Be subject to clinical follow-up for five years.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
70mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
May 2023May 2032

First Submitted

Initial submission to the registry

April 14, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

May 23, 2023

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2032

Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

8.9 years

First QC Date

April 14, 2023

Last Update Submit

December 10, 2024

Conditions

Cervix CancerEndometrial CancerEpithelial Ovarian Cancer

Keywords

Positron Emission Tomography-Computed TomographyMagnetic Resonance ImagingCervix CancerEndometrial CancerEpithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (4)

  • Progression-free survival (PFS) and overall survival (OS)

    PFS and OS at 3 months

    3 months

  • Progression-free survival (PFS) and overall survival (OS)

    PFS and OS at 6 months

    6 months

  • Progression-free survival (PFS) and overall survival (OS)

    PFS and OS at 1 year

    1 year

  • Progression-free survival (PFS) and overall survival (OS)

    PFS and OS at 5 years

    5 years

Secondary Outcomes (14)

  • Incidence of radiation therapy side effects

    3 months

  • Incidence of radiation therapy side effects

    6 months

  • Incidence of radiation therapy side effects

    1 year

  • Incidence of radiation therapy side effects

    5 years

  • Degree of agreement between FDG-PET/MRI and sentinel node histopathology

    0 months

  • +9 more secondary outcomes

Study Arms (3)

Cervix cancer

Newly diagnosed cervix cancer.

Diagnostic Test: FDG-PET/CT and FDG-PET/MRI

Endometrial cancer

Newly diagnosed endometrial cancer.

Diagnostic Test: FDG-PET/CT and FDG-PET/MRI

Ovarian cancer

Strong suspicion of newly diagnosed epithelial ovarian cancer; histopathological confirmation required within 6 months after inclusion.

Diagnostic Test: FDG-PET/CT and FDG-PET/MRI

Interventions

FDG-PET/CT and FDG-PET/MRIDIAGNOSTIC_TEST

Intravenous injection of FDG 3 MBq/kg. Intravenous injection of Dotarem 279.3 mg/ml, 0.2 ml/kg.

Cervix cancerEndometrial cancerOvarian cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients from the Northern Swedish regions of Vasterbotten, Vasternorrland, Jamtland-Harjedalen and Norrbotten, referred to the gynecological- oncological department of Umea University Hospital with newly diagnosed cervical cancer stage \>1a, endometrial cancer type 2 and/or minimum stage 1, or strongly suspected epithelial ovarian cancer.

You may qualify if:

  • Previously untreated primary cervical, endometrial, or strongly suspected epithelial ovarian cancer.
  • Known clinical FIGO stage.
  • \>18 years old.
  • No other known current or previous malignancy within the last 10 years.

You may not qualify if:

  • Imaging findings suggestive of other primary malignancy.
  • Previously included suspected epithelial ovarian cancer, later confirmed to be other diagnosis than epithelial ovarian cancer or "cancer abdominis".
  • MRI incompatible devices or patient unable to undergo MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Gynecology and Obstetrics, Umea University Hospital

Umeå, Sweden

RECRUITING

Related Publications (1)

  • Aasa M, Lindquist D, Ottander U, Strandberg SN. Primary staging with 2[18F]-FDG-PET/CT and -PET/MRI and radiotherapy response evaluation with MRI in uterine cervical cancer: an interim analysis of a prospective clinical trial. EJNMMI Rep. 2025 Jan 10;9(1):3. doi: 10.1186/s41824-024-00236-2.

    PMID: 39789229DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsCarcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Sara Strandberg, MD, PhD

    Department of Radiation Sciences, Umea University/Radiology, Umea University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erika Figaro

CONTACT

+46907850499erika.figaro@regionvasterbotten.se

Sara Strandberg, MD, PhD

CONTACT

+46907850000sara.strandberg@umu.se

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2023

First Posted

May 12, 2023

Study Start

May 23, 2023

Primary Completion (Estimated)

May 1, 2032

Study Completion (Estimated)

May 1, 2032

Last Updated

December 16, 2024

Record last verified: 2024-12

Locations

SE(1)