EUCTR2015-005546-63-ITActive, not recruitingPhase 1
Peptide receptor radionuclide therapy in tumors with high expression of somatostatine receptors. - DOTATER1_26_15
AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA0 sites120 target enrollmentStarted: January 28, 2021Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •patients older than 18
- •patients with neuroendocrine tumors or with high expression of somatostatin receptors tumors (at any anatomical site e.g. brain cancer, colorectal cancer, differentiated thyroid carcinoma, lymphoma, breast cancer, melanoma, lung cancer, renal cancer, sarcoma, prostate cancer, liver cancer, thymic neoplasms)
- •contrast Computed Tomography or Magnetic Resonance Imaging examination performed no longer than two months before the date of enrollment
- •68 Ga-SSA PET/CT examination performed no longer than two months before the date of enrollment and demonstrating the presence of lesions with high expression of somatostatin receptors
- •blood values within the estabilished ranges
- •ECOG performance status =2
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
Exclusion Criteria
- •pregnancy ( positive pregnancy test on serum)
- •refusal to stop breastfeeding
- •inadequate contraception
- •surgery, and/or chemotherapy, and/or radiation therapy (except for palliative radiation therapy) and /or biologics therapy performed in 4 four weeks before treatment
- •partecipation to other research protocols
- •bone marrow involvement >25%
- •life expectancy <6 months
- •inability to provide informed consent
Investigators
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