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Completed

NCT Number: NCT02976883

[18F]HX4 PET/CT Imaging for Detection of Hypoxia

The aim of this study is to investigate the radiotracer [18F]HX4 for non-invasive detection of hypoxia in patients with head and neck, or lung cancer. Each participant will undergo a diagnostic [18F]HX4 PET/CT scan before beginning radiotherapy treatment. Patient follow up data will be collected from routine appointments, and analysed with the hypoxia scan results to assess whether [18F]HX4 PET/CT scanning can predict patient outcome from radiotherapy treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with:
  • 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
  • squamous cell carcinoma of the upper aerodigestive tract 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 normal renal function, defined by creatinine clearance of >60 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, if appropriate, to be notified of participation in the study

Exclusion criteria

  • Patients who are scheduled for surgery prior to radiotherapy will not be included.
  • 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 (GFR <60 mL/min per 1.73 m3 for 3 months or more).
  • 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.
  • Previous cancer diagnosis.

Treatment and study plan

[18F]HX4 diagnostic PET/CT scan

Other

Single intravenous injection of [18F]HX4 and PET/CT scan

Primary outcomes

  1. The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy

    Time frame: 2 years

Secondary outcomes

  1. Collection of outcome data to determine number of participants with tumour recurrence or disease free survival 5 years after radiotherapy treatment.

    Time frame: 5 years

  2. Comparison of measurements of tumour/nodal disease areas on pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Registry information

Official study title

A Phase II, Single Centre Exploratory Study of [18F]HX4 PET/CT Imaging to Detect Hypoxia in Patients With Head and Neck and Lung Cancer, Receiving Radiotherapy With Curative Intent

Acronym: OXYPET

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2016
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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