uPAR-PET/CT for prognostication in head- and neck cancer

Phase II trial: uPAR-PET/CT for prognostication in head- and neck cancer

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002082-65-DK

Enrollment

Unknown

Registered

2016-09-19

Start date

2016-10-26

Completion date

Unknown

Last updated

2016-11-14

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

Conditions

Head and neck cancer MedDRA version: 19.0 Level: HLT Classification code 10026660 Term: Malignant oral cavity neoplasms System Organ Class: 100000004856 MedDRA version: 19.0 Level: HLT Classification code 10028801 Term: Oropharyngeal, nasopharyngeal and tonsillar neoplasms malignant and unspecified System Organ Class: 100000004864 MedDRA version: 19.0 Level: HLT Classification code 10023826 Term: Laryngeal neoplasms malignant System Organ Class: 100000004864

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patient has a diagnosis of biopsy-verified cancer of the pharynx, larynx or oral cavity, is referred to curative intended radiotherapy, understands the given information and has given informed consent and Age > 18 years 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 104 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy Lactation/breast feeding Age > 85 Years Obesity (bodyweight >140 kg) Small cancers of the larynx (1A/1B) Allergy to 68Ga-NOTA-AE105 Metastasis on the FDG-PET/CT Other previously known cancers Claustrophobia

Design outcomes

Primary

Measure	Time frame
Main Objective: 68Ga-NOTA-AE105-PET/CT will be evaluated as a prognostic tool in patients with head and neck cancer by observer-blinded readings and compared to the prognostic performance of FDG-PET/CT and prognostic biomarkers of head and neck cancer. ;Secondary Objective: Not applicable;Primary end point(s): Primary end point is ”freedom from any failure”. ;Timepoint(s) of evaluation of this end point: The primary and secondary end points are evaluated at follow-up after nearly tree years from the beginning of the study (autumn 2019)	—

Measure

Time frame

Main Objective: 68Ga-NOTA-AE105-PET/CT will be evaluated as a prognostic tool in patients with head and neck cancer by observer-blinded readings and compared to the prognostic performance of FDG-PET/CT and prognostic biomarkers of head and neck cancer. ;Secondary Objective: Not applicable;Primary end point(s): Primary end point is ”freedom from any failure”. ;Timepoint(s) of evaluation of this end point: The primary and secondary end points are evaluated at follow-up after nearly tree years from the beginning of the study (autumn 2019)

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary end points are ”overall survival” (OS), ”disease free survival” (DFS), ”distant metastasis free survival” (DMFS) og locoregional control.;Timepoint(s) of evaluation of this end point: same as for the primary end point	—

Countries

Denmark

Contacts

Public ContactLouise Madeleine Risør

Rigshospitalet KF 4011, Department of Fysiology, Nuclear Medicine and PET

louise.madeleine.risoer@regionh.dk004529896610

Outcome results

None listed

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