Molecular imaging before and during (chemo-) radiotherapy in patients with locally advanced Head and Neck, thoracic and pelvic tumors: prognostic and predictive value of 18F-fluoroazomycin arabinoside-PET/CT in head and neck squamous cell carcinoma.

Phase 1

• Conditions: Head and neck squamous cell carcinoma (HNSCC); MedDRA version: 19.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005278-40-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-09
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Patients randomized in any of the two arms of EORTC 1219 trial
- No contraindication to FAZA-PET/CT: pregnant or breast-feeding woman; for woman subject of childbearing potential, a pregnancy test will be done within 72 hours before the examination.
- No contraindication to contrast MRI:
= Pregnant woman (pregnancy test will be done within 72 hours before exam)
= Patient with metallic implant as vascular clips, cochlear implants or metal foreign body
= Patient with cardiac pacemaker or implanted cardioverter-defibrillator
= Renal insufficiency (glomerular filtration rate GFR < 30ml/min)
- Patients must be scanned on a PET/CT scanner accredited, and in compliance with the provided imaging guidelines.
- Biopsy must be performed 2 weeks before imaging scans.
- Patient must have given written informed consent to participate to the imaging sub-study.
- Delay between the baseline scans (FAZA-PET/CT and multiparametric MRI) and the start of the radiotherapy < 7 days.
- Patients with at least one measurable lesion at baseline defined as a lesion larger than 2 cm in diameter.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- All patient failing one or more of the inclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified