Phase II trial: PET/CT for staging advanced and localized oral and oropharyngeal cancer

Phase 1

• Conditions: Oral squamous cell cancer (OSCC) with and with out local metastasisOropharyngeal squamous cell cancer (OPSCC) with and with out local metastasis; MedDRA version: 21.1Level: LLTClassification code 10073040Term: Metastatic oropharyngeal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10030961Term: Oral cancer stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1Level: HLTClassification code 10028801Term: Oropharyngeal, nasopharyngeal and tonsillar neoplasms malignant and unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10031096Term: Oropharyngeal cancerSystem 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: EUCTR2016-002360-14-DK
• Lead Sponsor: Rigshospitalet, Dapartment of of Clinical Physiology, Nuclear Medicine and PET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-27
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Able to understand patient information and to give informed consent
• Not previously irradiated or operated on neck

study I
OSCC or OPSCC cN0 verified histologically by pathologic examination of biopsy

study II
OSCC or OPSCC N + verified histologically by pathologic examination of biopsy
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

• Pregnancy
• Patients who are candidates for curative intentional radiation
• Patients who have had surgery or radiation therapy to the neck as this may alter the lymph drainage.
• Other diseases assessed by the investigator as basis for exclusion.
• Age under 18 or over 85 years
• Obesity> 140 kg

Study & Design

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