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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002360-14-DK

Enrollment

Registered

2016-07-27

Start date

2016-09-29

Completion date

Unknown

Last updated

2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral squamous cell cancer (OSCC) with and with out local metastasis Oropharyngeal squamous cell cancer (OPSCC) with and with out local metastasis MedDRA version: 21.1 Level: LLT Classification code 10073040 Term: Metastatic oropharyngeal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10030961 Term: Oral cancer stage unspecified System Organ Class: 10029104 - Neoplasms benign, malignan

Interventions

Product Name: 68Ga-NOTA-AE105 Product Code: 68Ga-NOTA-AE105 Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN: 68Ga-NOTA-AE105 Current Sponsor code: 68Ga-NOTA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Able to understand patient information and to give informed consent • Not previously irradiated or operated on neck OSCC or OPSCC referred to primary surgical treatment 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the diagnostic value of uPAR-PET/CT with the current imaging options (CT, MRI and ultrasound). The reference that will be used as "gold standard" is the pathological examination of the surgically removed tissues. ;Secondary Objective: Not applicable;Primary end point(s): 1. The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.;Timepoint(s) of evaluation of this end point: The primary end point will be evaluated from the PET/scan and compared with the histological findings postoperatively.	—

Measure

Time frame

Main Objective: To compare the diagnostic value of uPAR-PET/CT with the current imaging options (CT, MRI and ultrasound). The reference that will be used as "gold standard" is the pathological examination of the surgically removed tissues. ;Secondary Objective: Not applicable;Primary end point(s): 1. The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.;Timepoint(s) of evaluation of this end point: The primary end point will be evaluated from the PET/scan and compared with the histological findings postoperatively.

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Secondary

Measure	Time frame
Secondary end point(s): 1. 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). 2. Evaluation of the correlation between tumor burden (assessed by TNM staging) uPAR-PET signal (assessed as SUVmax) and the amount of uPAR metabolites in plasma. 3. 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);Timepoint(s) of evaluation of this end point: The secondary end points will be evaluated from the PET/scan and compared with the histological findings and blood sample postoperatively.	—

Measure

Time frame

Secondary end point(s): 1. 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). 2. Evaluation of the correlation between tumor burden (assessed by TNM staging) uPAR-PET signal (assessed as SUVmax) and the amount of uPAR metabolites in plasma. 3. 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);Timepoint(s) of evaluation of this end point: The secondary end points will be evaluated from the PET/scan and compared with the histological findings and blood sample postoperatively.

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Countries

Denmark

Contacts

Public ContactMads Lawaetz

Rigshospitalet, Department of otorhinolaryngology,

mads.lawaetz@regionh.dk004540888701

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026