NCT03262311

Brief Summary

The purpose of this study is to test the potential of a relatively simple serum assay that aims to identify patient subpopulations whose curative radiotherapy outcome is likely to be compromised by radiobiological tumour hypoxia (prognostic value) and who are most likely to gain (predictive value) from the addition of radiation sensitiser drugs or targeted radiotherapy dose escalation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Nov 2017

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

August 17, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 10, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2019

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

1.8 years

First QC Date

August 17, 2017

Last Update Submit

December 20, 2019

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Detectable pimonidazole staining

    Number of cancer patients with detectable pimonidazole staining in extracellular vesicles isolated from blood samples after a single dose of pimonidazole

    24 hours and 2 weeks (+/- 5 days)

Study Arms (1)

Hypoxia marker

EXPERIMENTAL

Administration of a single dose of the hypoxia marker Pimonidazole

Other: Hypoxia marker

Interventions

Hypoxia markerOTHER

Single oral dose of pimonidazole 500 mg/m2

Also known as: Pimonidazole
Hypoxia marker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients i) Age ≥18 years ii) Biopsy-proven invasive carcinomas of head and neck, lung, bladder, uterine cervix or breast iii) Bulky (≥4 cm or ≥ 30 cc) primary/locally recurrent tumour or regional node masses iv) No clinical evidence of distant metastases unless oligometastases (ie distant relapse in only a limited number of regions for which local ablative therapy could be curative) v) Patient due for surgery, radiotherapy, systemic therapy or no anti-cancer treatment vi) Written informed consent
  • Healthy volunteers i) Age ≥18 years ii) Written informed consent

You may not qualify if:

  • Patients i) Inadequate cognitive ability to undertake the appropriate informed consent procedure
  • Healthy volunteers i) Past history of cancer, apart from non-melanomatous skin cancer or in situ carcinoma uterine cervix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pimonidazole

Study Officials

  • Navita Somaiah

    Institute of Cancer Research, United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 25, 2017

Study Start

November 10, 2017

Primary Completion

September 12, 2019

Study Completion

September 12, 2019

Last Updated

December 23, 2019

Record last verified: 2019-12

Locations

GB(1)