Back to results[18F]HX4 PET/CT Imaging for Detection of Hypoxia (OXYPET)
Primary Purpose
Head and Neck Cancer, Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
[18F]HX4 diagnostic PET/CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring Hypoxia, HX4, PET CT, Radiotherapy
Eligibility Criteria
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.
Sites / Locations
- Nottingham University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F]HX4 diagnostic PET/CT scan
Arm Description
[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.
Outcomes
Primary Outcome Measures
The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy
Secondary Outcome Measures
Collection of outcome data to determine number of participants with tumour recurrence or disease free survival 5 years after radiotherapy treatment.
Comparison of measurements of tumour/nodal disease areas on pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images
Full Information
NCT ID
NCT02976883
First Posted
August 24, 2016
Last Updated
January 10, 2019
Sponsor
Nottingham University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02976883
Brief Title
[18F]HX4 PET/CT Imaging for Detection of Hypoxia
Acronym
OXYPET
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 31, 2015 (Actual)
Primary Completion Date
July 25, 2017 (Actual)
Study Completion Date
July 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Lung Cancer
Keywords
Hypoxia, HX4, PET CT, Radiotherapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[18F]HX4 diagnostic PET/CT scan
Arm Type
Experimental
Arm Description
[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.
Intervention Type
Other
Intervention Name(s)
[18F]HX4 diagnostic PET/CT scan
Intervention Description
Single intravenous injection of [18F]HX4 and PET/CT scan
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan C Perkins, PhD
Organizational Affiliation
Nottingham University Hospitals NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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[18F]HX4 PET/CT Imaging for Detection of Hypoxia
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