Status:
UNKNOWN
Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors (Phase 2)
Lead Sponsor:
University Hospital of Ferrara
Conditions:
Neuroendocrine Tumors
Peptide Receptor Radionuclide Therapy (PRRT)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The rationale behind the purpose of this study lays on: * the evidence that PRRT could represent a valuable treatment for the majority of patients with neuroendocrine tumor (NET) in disease progressi...
Eligibility Criteria
Inclusion
- 1\. Age ≥18 years, of both sexes, of any ethnicity;
- 2\. Cyto-histological and immunohistochemical diagnosis of NET;
- 3\. Evaluation of the cell proliferation index by studying Ki-67 and / or E3 ubiquitin-protein ligase (MIB-1).
- 4\. Illness measurable according to RECIST 1.1 criteria by imaging conventional (CT with contrast medium or MRI with contrast medium) not earlier than two months with respect to enrollment;
- 5\. Elevated expression of somatostatin receptors documented by PET-CT with 68Ga-DOTATOC in the target lesion (s). It is defined as "high expression of somatostatin receptors "a ratio of Maximum standardized uptake value (SUVmax) lesion / Mean standardized uptake value (SUVmean) muscle ≥ 4: 1 calculated with semi-quantitative analysis on examination PET-CT with 68Ga-DOTATOC;
- 6\. Dosage of Chromogranin A (and any other specific markers) not prior to two months of enrollment;
- 7\. Evaluation of glucose metabolism in the target lesion (s) by PET-CT with 18F-FDG;
- 8\. Preserved haematological, hepatic and renal parameters, in particular: white blood cells ≥2500 / μL; platelets ≥ 90000 / μL; hemoglobin ≥ 9 gr / dL; creatinine ≤ 2 mg / dL; bilirubin ≤ 2.5 mg / dL
- 9\. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
- 10\. Life expectancy ≥ 6 months;
- 11\. Stable or progressive disease, at any stage, both in operated patients that inoperable;
- 12\. Absence of standard treatments already documented and of equal effectiveness;
- 13\. Absence of surgical, chemotherapy and / or radiotherapy treatments for at least 30 days. On the other hand, patients in therapy with somatostatin analogues or biologics, such as mechanistic target of rapamycin (m-TOR) inhibitors;
- 14\. Voluntary participation in the study by signing the consent form informed, after reading and complete understanding of the information notes.
Exclusion
- 1\. Lack of the requirements listed above;
- 2\. State of pregnancy;
- 3\. Breastfeeding and relative refusal to suspend breastfeeding;
- 4\. Participation in another therapeutic experimental clinical protocol in the four weeks prior to the PRRT;
- 5\. Bone marrow invasion of disease\> 25% confirmed;
- 6\. Previous extensive radiotherapy treatments.
Key Trial Info
Start Date :
July 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04790708
Start Date
July 2 2018
End Date
June 30 2023
Last Update
March 10 2021
Active Locations (1)
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1
University Hospital of Ferrara
Ferrara, Italy, 44124