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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Nottingham University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [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.	Other: [18F]HX4 diagnostic PET/CT scan; Single intravenous injection of [18F]HX4 and PET/CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Investigators: Study Chair: Alan C Perkins, PhD, Nottingham University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2015
• Primary Completion (Actual): July 25, 2017
• Study Completion (Actual): July 25, 2017

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: November 25, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Hypoxia; Radiotherapy; PET CT; HX4
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Signs and Symptoms, Respiratory; Lung Neoplasms; Hypoxia
• Other Study ID Numbers: 13MP003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED