PET With [18F]HX4 in Head and Neck Cancer

NCT01347281 | Completed DMC

• 2 other identifiers: 11-12-23/03-intern-64702011-001812-80
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to (i) Determine if tumor hypoxia can be accurately visualised with \[18F\] HX4 PET imaging in head and neck tumors (ii) correlate the \[18F\] HX4 PET images with blood and tissue markers and (iii) investigate the quality and optimal timing of \[18F\] HX4 PET imaging (iv) compare \[18F\] HX4 PET uptake with \[18F\] FDG PET uptake before and after treatment.

Conditions

Cancer of the Head and Neck

Keywords

Cancer of the Head and Neck; [18F]HX4; hypoxia; PET; phase II trial

Outcome Measures

Primary Outcomes (1)

• Visualisation of tumor hypoxia with [18F] HX4 PET imaging

  Visualisation of tumor hypoxia with \[18F\] HX4 PET imaging

  2 years

Secondary Outcomes (8)

• Observe spatial and temporal stability of [18F] HX4 PET images

  2 years

• Correlation of [18F] HX4 with local tumor recurrence and survivalG PET

  2 years

• Image quality of [18F] HX4-PET at different time points

  2 years

• Kinetic analysis of HX4

  2 years

• Correlation of hypoxia imaging with blood hypoxia markers

  2 years

Study Arms (1)

[18F]HX4 PET

EXPERIMENTAL

Injection of \[18F\]HX4

Procedure: Injection of [18F]HX4

Interventions

Injection of [18F]HX4 PROCEDURE

Injection of \[18F\]HX4 before treatment (baseline) and after radiotherapy with 20 +/-4 Gy: \[18F\]HX4 PET scans; 444 MBq (12 mCi) \[18F\]HX4 administrated via a bolus IV injection. Image acquisition: static scan at 240 min p.i. Venous blood sampling: before injection of \[18F\]HX4 (blood hypoxia markers) Follow-up (3 months after treatment): \[18F\]FDG PET in treatment position

[18F]HX4 PET

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological confirmed HNSSC of the oral cavity, oropharynx, hypopharynx, larynx, T2-T3-T4, any N, M0
• Tumor diameter ≥ 2,5 cm
• WHO performance status 0 to 2
• Scheduled for primary curative (concurrent chemo-) radiotherapy
• No previous surgery to the head and neck
• No previous radiation to the head and neck
• Adequate renal function (calculated creatinine clearance at least 60 ml/min).
• The patient is willing and capable to comply with study procedures
• years or older
• Have given written informed consent before patient registration

You may not qualify if:

• No recent (\< 3 months) myocardial infarction
• No Uncontrolled infectious disease
• Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

Maastricht Radiation Oncology (MAASTRO clinic)

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Hypoxia

Interventions

3-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1-yl)propan-1-ol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philppe Lambin, Prof. Dr.

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 4, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 30, 2017

Record last verified: 2017-01

Locations

NL (1)