Clinical trial NCT02976883: [18F]HX4 PET/CT Imaging for Detection of Hypoxia
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lung Cancer
Keywords: Hypoxia
HX4
PET CT
Radiotherapy
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy
timeFrame: 2 years
Secondary outcomes:
measure: Collection of outcome data to determine number of participants with tumour recurrence or disease free survival 5 years after radiotherapy treatment.
timeFrame: 5 years
measure: Comparison of measurements of tumour/nodal disease areas on pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images
timeFrame: 5 years
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Alan C Perkins, PhD
role: STUDY_CHAIR
References: