NCT04001023

Brief Summary

The goal of this non-randomized prospective study is to use 18F-EF5-PET/CT imaging to identify and locate intraabdominal hypoxic ovarian cancer lesions. With targeted surgical sampling, precisely obtain hypoxic and potentially chemoresistant cancer tissue for our analyses and identify key molecular differences between hypoxic and non-hypoxic tumors within the same patient. A portion of advanced stage EOC are inoperable at diagnosis and can be treated with neoadjuvant chemotherapy (NACT) before surgery. This approach offers a unique opportunity to study how hypoxic tumor areas respond to treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

March 9, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

5.8 years

First QC Date

January 11, 2019

Last Update Submit

August 5, 2019

Conditions

Epithelial Ovarian CancerFallopian Tube CancerPeritoneal CarcinomaHypoxia

Keywords

advanced ovarian cancerEF5-PET/CThypoxia

Outcome Measures

Primary Outcomes (1)

  • 18F-EF5 maximum standardized uptake values (SUVmax)

    Tumor and musculus gluteus maximus SUVmax ratio ≥1.5 is considered to refer to hypoxia

    2-3 years

Secondary Outcomes (3)

  • Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue

    2-3 years

  • Disease-free survival

    5 years

  • Overall survival

    5 years

Study Arms (2)

PDS

EXPERIMENTAL

18F-EF5 PET/CT and 18F-FDG PET/CT scan prior to primary cytoreductive surgery and targeted sample collection during primary cytoreductive surgery

Device: Imaging with 18F-EF5 PET/CT

IDS

EXPERIMENTAL

18F-EF5 PET/CT and 18F-FDG PET/CT scans prior to diagnostic laparoscopy and after neoadjuvant chemotherapy before interval cytoreductive surgery . Targeted sample collection during diagnostic laparoscopy and interval cytoreductive surgery

Device: Imaging with 18F-EF5 PET/CT

Interventions

Imaging with 18F-EF5 PET/CTDEVICE

Both 18F-FDG PET/CT and 18F-EF5 PET/CT imaging are performed in 1) preoperative work-up to clarify the disease distribution, 2) before IDS to evaluate treatment response to NACT (IDS arm); targeted samples from hypoxic and non-hypoxic tumors are collected during surgery

Also known as: Collection of targeted samples during surgery
IDSPDS

Eligibility Criteria

Age18 Years - 79 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • previous cancer
  • pregnancy or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University hospital

Turku, 20521, Finland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube NeoplasmsHypoxia

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Maren Laasik, MD

CONTACT

+35823130000maren.laasik@utu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2019

First Posted

June 27, 2019

Study Start

March 9, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2025

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

FI(1)