NCT03982355

Brief Summary

Laboratory based study in which novel tissue oxygenation probe with the potential provide novel means for assessing response to cancer treatment will be developed and validated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 22, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 9, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

May 22, 2019

Results QC Date

January 31, 2022

Last Update Submit

April 25, 2024

Conditions

Keywords

Cancer

Outcome Measures

Primary Outcomes (1)

  • Count of MRIs Successfully Modelled for Oxygen Correlation

    Number of MRIs 3D modelled for oxygenation sensor development Note: this outcome measure was orginally expressed as "Oxygenation Correlation" though this was modeled and therefore we have expressed it as above

    MRIs were 3D modelled - single time point at time of MRI

Study Arms (2)

Breast Cancer

Anonymised MRI scans (pre-therapy) of locally advanced breast cancer sufferers.

Device: DRS probe

Rectal Cancer

Anonymised MRI scans (pre-therapy) of locally advanced rectal cancer sufferers.

Device: DRS probe

Interventions

DRS probeDEVICE

The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe

Breast CancerRectal Cancer

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pretreatment anonymised MRIs from (locally advanced) breast and rectal cancer sufferers

You may qualify if:

  • MRIs from Breast or Rectal Cancer patients (10 of each)
  • Locally advanced Cancers (Stage 2 or 3)
  • Patients who went on to receive neoadjuvant chemoradiotherapy.
  • Anonymised scans

You may not qualify if:

  • MRIs from patients under the age of 18, or older than 99 years old will be excluded.
  • MRIs from patients who did not receive neoadjuvant therapy for cancer will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, Greater London, W21NY, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

Title
Dr SImon Dryden
Organization
IMperial COllege London

Study Officials

  • Ara Darzi

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2019

First Posted

June 11, 2019

Study Start

August 9, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

The anonymised scans will be used for this study alone. The participant identifiable data will not be available to our research team, and the scan data will not be made available outside of the research team.

Locations