uPAR-PET - a new method for determining lymph node metastases in breast cancer patients

Phase II trial: uPAR-PET for preoperative staging of breast cancer patients - Phase II trial: uPAR-PET for preoperative staging of breast cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004503-23-DK

Enrollment

Unknown

Registered

2015-11-19

Start date

2015-12-17

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

breast cancer MedDRA version: 18.1 Level: LLT Classification code 10006192 Term: Breast cancer NOS System Organ Class: 100000004864

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 CAS Number: NA Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Biopsy-verified breast cancer Primary tumor more than 2 cm (ultrasound or clinically) The participants must be capable of understanding and giving full informed written consent age above 18 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Pregnancy Lactation/breast feeding Age above 85 years old Weight above 140 kg Treatment with neoadjuvant chemotherapy Known allergy towards the IMP

Design outcomes

Primary

Measure	Time frame
Main Objective: The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT for detection of lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative diagnostic workup procedures. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND). Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla;Secondary Objective: Number of axillary lymph node metastasis Detection of distant metastases. For possible detected distant metastases biopsy/follow up imaging will be used as reference. ;Primary end point(s): Primary end point dicotomized: +/- lymph node metastases in ipsilateral axil ;Timepoint(s) of evaluation of this end point: Evaluation of the primary endpoints from PET scans performed within 1 hour post injection of 68Ga-NOTA-AE105	—

Measure

Time frame

Main Objective: The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT for detection of lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative diagnostic workup procedures. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND). Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla;Secondary Objective: Number of axillary lymph node metastasis Detection of distant metastases. For possible detected distant metastases biopsy/follow up imaging will be used as reference. ;Primary end point(s): Primary end point dicotomized: +/- lymph node metastases in ipsilateral axil ;Timepoint(s) of evaluation of this end point: Evaluation of the primary endpoints from PET scans performed within 1 hour post injection of 68Ga-NOTA-AE105

—

Secondary

Measure	Time frame
Secondary end point(s): Number of axillary lymph node metastases Detection of distant metastases;Timepoint(s) of evaluation of this end point: Evaluation of secondary endpoints from PET scan performed within 1 hour post injection of 68Ga-NOTA-AE105	—

Countries

Denmark

Contacts

Public ContactDorthe Skovgaard

Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET

dskovgaard@dadlnet.dk004561274706

Outcome results

None listed

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