Valutation of expression of receptors SSTR2 and/or 5 in neoplastic patients MedDRA version: 9.1 Level: HLGT Classification code 10022893 Term: Investigations, imaging and histopathology procedures NEC
Conditions
Interventions
Product Name: 68 Ga-DOTATOC
Pharmaceutical Form: Kit for radiopharmaceutical preparation
Other descriptive name: 68Ga-DOTATOC (DOTA-D-Phe1-Tyr-octreotide)
Concentration unit: MBq megabecquerel(s)
Conc
Sponsors
AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Pregnancy (breast feeding will be interrupted)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Goals of the study are: to obtain better sensitivity and accuracy in post-surgical staging, in evaluation of the entity of disease spread in non surgical patients, in defining the primitive site in patients with evidence of metastases or secretion syndrome, restaging in the suspicion of relapse or metastases for evaluation for therapy with 90Y o 177Lu DOTATOC or DOTATATE, if in presence of SSTR2 and/or 5 receptors and in absence of documented therapeutic alternatives.;Secondary Objective: 1. detection of the primary lesion, if present 2. metastastatic lesions > 2 cms 3. in case of extreme metastatic spread (massive secondary infiltration that can interest just one organ, but with lesions that cannot be counted), the comparative evaluation will only be qualitative;Primary end point(s): Selection of patients to trial with 90Y-DOTATOC | — |
Countries
Italy
Outcome results
None listed