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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02960724
Other study ID # AK-2016-HHC1
Secondary ID
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


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
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