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

Phase 1

Conditions: breast cancer
MedDRA version: 18.1Level: LLTClassification code 10006192Term: Breast cancer NOSSystem Organ Class: 100000004864
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Registration Number: EUCTR2015-004503-23-DK

Lead Sponsor: Rigshospitalet, Department of Clinical Physiology, Nucelar Medicine and PET

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): Number of axillary lymph node metastases<br>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