NCT03466034

Brief Summary

The study aims to develop scans that tell the investigators about the oxygen content of tumours using Magnetic Resonance Imaging (MRI) and seeing whether regions of low oxygen content are related to mutations in cancer genes such as TP53. MRI is a method of obtaining pictures of inside of the body that shows the appearance and structure of soft tissues. To get the information about the oxygen content of tumours, MRI is carried out while breathing 100% oxygen. The variation of oxygen supply to different regions of the tumour will help the investigators to predict tumour behavior and tumour response to treatment.

Trial Health

57
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Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

February 12, 2018

Last Update Submit

January 27, 2020

Conditions

Endometrial Cancer

Keywords

TP53HypoxiaEndometriod and Mucinous CarcinomasSerous and Clear Cell CarcinomasMagnetic Resonance Imaging, MRI

Outcome Measures

Primary Outcomes (1)

  • Establish distinctive patterns of distribution and expression of mutant TP53 between tumour regions with differing levels of oxygenation (as measured by R2*on MRI).

    Determined at post surgery histology

    Duration of study (24 months)

Secondary Outcomes (2)

  • The reproducibility of the R2* measurement, assessed by comparing 2 R2* scans per person

    6 months

  • Establish the range of intratumoral heterogeneity of the R2* measurement within individual tumours

    6 months

Study Arms (2)

Endometriod

Type I (endometrioid and mucinous carcinomas) - Magnetic Resonance Imaging (MRI) with 100% Oxygen.

Serous

Type II (serous and clear cell carcinomas) - Magnetic Resonance Imaging (MRI) with 100% Oxygen.

Eligibility Criteria

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

Participants scheduled to have hysterectomy at the cancer centre

You may qualify if:

  • ≥18 years of age on the day of signing the informed consent.
  • Histologically confirmed endometroid or serous endometrial cancer.
  • Scheduled to have hysterectomy at the cancer centre
  • Identifiable tumour mass on staging MRI.
  • Voluntarily agreed to participate by giving written informed consent.

You may not qualify if:

  • Life expectancy of \< 6 months.
  • Ferromagnetic implants, contraindicating MRI
  • Claustrophobia so unable to tolerate MRI
  • Unable to lie flat
  • Ascites sufficient to prevent patient being fitted in the scanner bore
  • Histology unlikely to show variation in TP53 status, or heavily calcified disease.
  • Radiotherapy to the abdomen or pelvis within 6 months of the screening visit.
  • Unresolved bowel obstruction.
  • Currently participating or has participated in a study with an investigational compound or device within 30 days of the start of treatment.
  • History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
  • Unlikely to comply with the requirements of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Endometrial tumour tissue Blood

MeSH Terms

Conditions

Endometrial NeoplasmsHypoxiaAdenocarcinoma, Mucinous

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Cystic, Mucinous, and Serous

Study Officials

  • Nandita deSouza

    The Institution of Cancer Research & The Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2018

First Posted

March 15, 2018

Study Start

February 6, 2018

Primary Completion

June 19, 2018

Study Completion

July 30, 2019

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations

GB(1)