Peptide receptor radionuclide therapy in tumors with high expression of somatostatine receptors.

Phase 1

• Conditions: Cancer patients with high expression of somatostatin receptors (neurendocrine tumors, thyroid tumors, lung tumors, meningiomas).; MedDRA version: 21.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005546-63-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified