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

Phase 2

Completed

• Conditions: Lung Cancer; Head and Neck Cancer
• Interventions: Other: [18F]HX4 diagnostic PET/CT scan

• Registration Number: NCT02976883
• Lead Sponsor: Nottingham University Hospitals NHS Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-31
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-11-25
• Study First Posted: 2016-11-29
• Primary Completion: 2017-07-25
• Study Completion: 2017-07-25
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Patients with:

  1. 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
  2. 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]HX4 diagnostic PET/CT scan	[18F]HX4 diagnostic PET/CT scan	\[18F\]HX4 (370 MBq) will be administered by a single intravenous injection, after which patients will be required to wait for ≤4.0 h and undergo a PET/CT scan.

Primary Outcome Measures

Name	Time	Method
The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy	2 years

Secondary Outcome Measures

Name	Time	Method
Comparison of measurements of tumour/nodal disease areas on pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images	5 years
Collection of outcome data to determine number of participants with tumour recurrence or disease free survival 5 years after radiotherapy treatment.	5 years

Trial Locations

Locations (1)

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom