Imaging of newly formed blood vessels in tumors of the mouth and throat cavity

Phase 1

• Conditions: The aim of this study is to assess differences in tumour microenvironment between HPV positive and HPV negative oropharyngeal head and neck squamous cell carcinoma using [68Ga]Ga-RGD2 PET/CT and perfusion CT; MedDRA version: 20.0 Level: LLT Classification code 10031117 Term: Oropharyngeal squamous cell carcinoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10031112 Term: Oropharyngeal squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10031116 Term: Oropharyngeal squamous cell carcinoma stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10031115 Term: Oropharyngeal squamous cell carcinoma stage I System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2019-001843-37-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-04
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Patients with a histologically proven OHNSCC;
- P-16 immunohistochemical analysis to determine HPV status of the tumour;
- A primary tumour lesion with a diameter of at least 1.0 cm concluded from a diagnostic CT, MRI or FDG PET/CT scan within 4 weeks prior to intake;
- Planned chemoradiotherapy as primary treatment;
- Age of at least 18 years;
- Ability to provide written informed consent.

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Contra-indication for (PET/)CT: Pregnancy; Breast-feeding; Severe claustrophobia.
- Contra-indication for administration of iodine-containing contrast agents.
- Other serious illness, e.g. history of malignancies
- Estimated creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula

Study & Design

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