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

Neoplasms Clinical Trial

Official title:

Phase II Trial: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02960724
• Other study ID #: AK-2016-HHC1
• Status: Recruiting
• Phase: Phase 2
• First received: October 11, 2016
• Last updated: November 7, 2016
• Start date: November 2016
• Est. completion date: August 2018

Study information

• Verified date: November 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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 +).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cancer of Mouth
• Head and Neck Neoplasms
• Mouth Neoplasms
• Neoplasms
• Neoplasms by Site
• Oral Cancer
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Other:
• 68Ga-NOTA-AE105 PET/CT
One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.

Locations

Country	Name	City	State
Denmark	Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Persson M, Nedergaard MK, Brandt-Larsen M, Skovgaard D, Jørgensen JT, Michaelsen SR, Madsen J, Lassen U, Poulsen HS, Kjaer A. Urokinase-Type Plasminogen Activator Receptor as a Potential PET Biomarker in Glioblastoma. J Nucl Med. 2016 Feb;57(2):272-8. doi — View Citation

Persson M, Skovgaard D, Brandt-Larsen M, Christensen C, Madsen J, Nielsen CH, Thurison T, Klausen TL, Holm S, Loft A, Berthelsen AK, Ploug M, Pappot H, Brasso K, Kroman N, Højgaard L, Kjaer A. First-in-human uPAR PET: Imaging of Cancer Aggressiveness. The — View Citation

Skovgaard D, Persson M, Brandt-Larsen M, Christensen C, Madsen J, Klausen TL, Holm S, Andersen FL, Loft A, Berthelsen AK, Pappot H, Brasso K, Kroman N, Hoejgaard L, Kjaer A. Safety, dosimetry and tumor detection ability of 68Ga-NOTA-AE105 - a novel radiol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No