Diagnostic procedure with 68Ga-labelled somatostatin analogues in tumours presumably expressing SSTR2 and/or 5 receptors, to be evaluated for treatment with the same analogues labelled with 90Y o 177Lu - ND

• Conditions: Valutation of expression of receptors SSTR2 and/or 5 in neoplastic patients; MedDRA version: 9.1Level: HLGTClassification code 10022893Term: Investigations, imaging and histopathology procedures NEC

• Registration Number: EUCTR2008-000983-17-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients in need of the diagnostic procedure described above will be appointed by the endocrinological, oncological, medical or other centres or wards, or other hospitals, with the clinical information necessary to evaluate its appropriateness; the final decision shall be taken by the Nuclear Physician after an accurate evaluation of each patient?s clinical situation.
In respect to the actual laws, the patient will be properly informed on the procedure and objectives of the scan, and asked to give written consent.

§Patients of both sexes aged > 18 (for patients younger a specific authorisation will be submitted to this Ethics Committee), with histologically documented primitive tumour presumably expressing SSTR2 and/or 5: the main clinical question will be research of metastatic lesions in presence of a rise of specific markers or of symptoms due to hormonal incretion in productive neoplasms; in cases of advanced or metastatic disease, 68Ga DOTATOC or 68GaDOTATATE PET scan may be used as a preliminary step for treatment with the analogues labelled with beta- emitters; not only neuroendocrine tumours, but also thyroid, breast pulmonary SCLC and brain neoplasms shall be considered, these forms being susceptible to the above mentioned treatment only if positive to the diagnostic scan.

§Patients? consent to take part in the study, with written consent

In case of female patients in fertile age, the procedure will be performed exclusively in presence of a negative pregnancy test.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy (breast feeding will be interrupted)

Study & Design

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