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
Phase 1
- Conditions
- Patient with untreated or reccurent breast cancer, non-small cell lung cancer, colorectal cancer and neuroendocrine tumorsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2018-001016-30-AT
- Lead Sponsor
- Department of Nuclear Medicine, Medical University Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 24
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
• Karnovsky Index <75%
• Advanced renal insufficiency with an eGFR below 30 ml/min
• Pregnancy or nursing period
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable