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Clinical Trials/EUCTR2013-003563-58-GB
EUCTR2013-003563-58-GB
Active, not recruiting
Phase 1

A Phase II, single-centre exploratory study to assess the value of hypoxia imaging with [18F]HX4 PET/CT in predicting outcome for patients with squamous cell carcinoma of head and neck and non-small cell lung cancer undergoing radical radiotherapy with curative intent (OXYPET Study) - [18F]HX4 PET/CT Imaging for Detection of Hypoxia (OXYPET Study) V1

ottingham University Hospitals NHS Trust0 sites3 target enrollmentDecember 9, 2013

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ottingham University Hospitals NHS Trust
Enrollment
3
Status
Active, not recruiting
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 9, 2013
End Date
July 25, 2017
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
ottingham University Hospitals NHS Trust

Eligibility Criteria

Inclusion Criteria

  • Patients with:
  • (a) biopsy proven non\-small cell carcinoma of the lung \>2\.5 cm in size with any T and N status but M0 who have elected to undergo radical radiotherapy or chemo\-radiotherapy with curative intent or
  • (b)squamous cell carcinoma of the upper aerodigestive tract (excluding oesophagus) with a primary tumour or nodal mass \>2\.5 cm in size, with any T and N status but M0 who have elected to undergo radical radiotherapy or chemo\-radiotherapy with curative intent.
  • Participant must be willing and able to give informed consent for participation in the study.
  • Patients must be 18 years old or above.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\.
  • Have adequate renal function, defined by creatinine clearance of \>30 mL/min.
  • Able to remain still in the supine position on the scanner bed for the 40 minute duration of the examination.
  • Able (in the Investigators opinion) and willing to comply with all study requirements.
  • Willing to allow his or her General Practitioner and hospital consultant to be notified of participation in the study.

Exclusion Criteria

  • Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
  • Chronic kidney disease stage III or worse, as defined by the NKF clinical practice guidelines.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of involvement in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
  • Participants who have been involved in another research study involving an investigational product in the past 12 weeks.
  • Previous surgery or radiotherapy to the upper aerodigestive tract or lung, which in the opinion of the Investigators could compromise the data.
  • Patient is a prisoner.
  • Previous cancer diagnosis.

Outcomes

Primary Outcomes

Not specified

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