uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer

Phase 2

• Conditions: Oropharyngeal Cancer; Head and Neck Neoplasms; Cancer of Mouth; Neoplasms by Site; Neoplasms; Oral Cancer
• Interventions: Other: 68Ga-NOTA-AE105 PET/CT

• Registration Number: NCT02960724
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer

Detailed Description

To compare the diagnostic value of uPAR-PET/CT for prognostication compared to the current imaging options (CT, MRI and ultrasound) by observer-blinded readings. The reference that will be used as "gold standard" is the pathological examination of the surgically removed tissues.

The new imaging modality (uPAR-PET/CT) will be used in two separate groups of patients with head and neck cancer:

Study I:

Patients with oral cancer without clinical evidence of spread (OSCC in stage cN0)

Study II:

Patients with metastatic oral cancer (OSCC in stage cN +) and patients with metastatic oropharyngeal cancer (OPSCC in stage cN +).

Study Timeline

• Study First Submitted: 2016-10-11
• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-07
• Last Update Submitted: 2016-11-07
• Study First Posted: 2016-11-10
• Last Update Posted: 2016-11-10
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Study I OSCC cN0 verified histologically by pathologic examination of biopsy

Study II OSCC or OPSCC N + verified histologically by pathologic examination of biopsy

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
• Allergy to 68Ga-NOTA-AE105

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NOTA-AE105 PET/CT	68Ga-NOTA-AE105 PET/CT	One injection of 68Ga-NOTA-AE105 followed by positron emission tomography/computed tomography (PET/CT scan) will be performed before surgery and compared with the histological findings to evaluate uPAR PET/CT in staging of oral cancer and oropharyngeal cancer.

Primary Outcome Measures

Name	Time	Method
The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.	Through study completion, an average of 1.5 year

Secondary Outcome Measures

Name	Time	Method
Evaluation of the correlation between tumor burden (assessed v.h.a. TNM staging) uPAR-PET signal (assessed as SUVmax) and the amount of uPAR metabolites in plasma.	Through study completion, an average of 1.5 year
Determination of the lower detection limit of the amount of tumor tissue for uPAR-PET correlated with the histological H-score x tumor size (where tumor size is evaluated on the pathological preparation of pathologist)	Through study completion, an average of 1.5 year
Evaluation of the correlation between uPAR PET signal (quantified as SUVmax) and the immunohistochemical expression of uPAR evaluated by an H-score (intensity x the percentage of stained tumor tissues throughout the tumor margin).	Through study completion, an average of 1.5 year

Trial Locations

Locations (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet; 🇩🇰 Copenhagen, Denmark