Study to investigate the potential of 68GA-NODAGA-RGD-PET for the non-invasive determination of the expression of a receptor (integrin avß3) involved in the formation of new blood vessels during tumor development and metastasis including patients with breast cancer, colorectal cancer, non-small cell lung cancer or neuroendocrine tumors

PROSPECTIVE STUDY OF 68GA-NODAGA-RGD-PET FOR THE NON-INVASIVE DETERMINAITON OF THE INTEGRIN avß3 EXPRESSION IN PATIENTS WITH UNTREATED OR RECURRENT BREAST CANCER, COLORECTAL CANCER, NON-SMALL CELL LUNG CANCER OR NEUROENDOCRINE TUMORS - 68Ga-NODAGA-RGD-PET for tumor imaging

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001016-30-AT

Enrollment

Registered

2018-07-16

Start date

2018-12-11

Completion date

Unknown

Last updated

2019-01-07

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

Conditions

Patient with untreated or reccurent breast cancer, non-small cell lung cancer, colorectal cancer and neuroendocrine tumors

Interventions

Product Name: 68Ga-NODAGA-RGD Pharmaceutical Form: Solution for injection INN or Proposed INN: 68GA-NODAGA-RGD Other descriptive name: 68GA-NODAGA-RGD Concentration unit: Bq becquerel(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Untreated breast cancer, non-small cell lung cancer, colorectal cancer and neuroendocrine tumors • Written informed consent • Age 18 or above • In women, pregnancy must be excluded and contraception must be performed 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: • Karnovsky Index <75% • Advanced renal insufficiency with an eGFR below 30 ml/min • Pregnancy or nursing period

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective is to evaluate accumulation of 68Ga-NODAGA-RGD in patient with untreated or reccurent breast cancer, non-small cell lung cancer, colorectal cancer and neuroendocrine tumors and to correlate the tumor volume measured by 68Ga-NODAGA-RGD-PET to the tumor volume measured by CT/MRI.;Secondary Objective: Not applicable;Primary end point(s): If inclusion criteria are met, the patient will undergo one 68Ga-NODAGA-RGD-PET/CT;Timepoint(s) of evaluation of this end point: not applicable	—

Measure

Time frame

Main Objective: The objective is to evaluate accumulation of 68Ga-NODAGA-RGD in patient with untreated or reccurent breast cancer, non-small cell lung cancer, colorectal cancer and neuroendocrine tumors and to correlate the tumor volume measured by 68Ga-NODAGA-RGD-PET to the tumor volume measured by CT/MRI.;Secondary Objective: Not applicable;Primary end point(s): If inclusion criteria are met, the patient will undergo one 68Ga-NODAGA-RGD-PET/CT;Timepoint(s) of evaluation of this end point: not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Austria

Contacts

Public ContactProf. Dr. Irene Virgolini

Department of Nuclear Medicine, Medical University Innsbruck

Irene.Virgolini@i-med.ac.at004351250422651

Outcome results

None listed

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