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

Rigshospitalet

Status and phase: Unknown; Phase 2

Conditions: Oropharyngeal Cancer; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Cancer of Mouth; Oral Cancer

Treatments: Other: 68Ga-NOTA-AE105 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02960724

AK-2016-HHC1

Details and patient eligibility

About

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

Full 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 +).

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

68Ga-NOTA-AE105 PET/CT

Experimental group

Description:

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.

Treatment:

Other: 68Ga-NOTA-AE105 PET/CT