uclear Medicine therapy using synthetic somatostatin analogues that are radiolabelled with high-energy beta(-) emitting isotopes, for the treatment of tumors overexpressing somatostatin specific receptors (on the surface of the cell membrane) enable to bind and internalize the radiolabelled analogues mentioned above

Phase 1

• Conditions: Tumors over-expressing somatostatin receptors; MedDRA version: 20.0Level: HLTClassification code 10014712Term: Endocrine neoplasms malignant and unspecified NECSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-005129-35-IT
• Lead Sponsor: AZIENDA OSPEDALIERO UNIVERSITARIA DI FERRARA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Age = 18 years, of both sexes, of any ethnicity;
2. Hhistological and immunohistochemical diagnosis of NET;
3. Evaluation of the cell proliferation index by study of Ki-67 and/or MIB-1.
4. Disease measurable according to the RECIST 1.1 criteria by conventional imaging (TC with MDC or MRI with MDC) not before the two months of enlistment;
5. High expression of somatostatin receptors documented by PET-TC with 68Ga-DOTATOC in the target lesion (s). It is defined as high expression of the receptors for Somatostatin a report of SUVmax lesion/SUVmean muscle = 4:1 calculated with semi-quantitative analysis at the PET-TC examination with 68Ga-dotatoc;
6. Dosage of Chromogranin A (and any other specific markers) not prior to two months of enrolment;
7. Evaluation of glucose metabolism in the target lesion (s) by PET-TC with 18F-FDG;
8. Conserved 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. ECOG performance status = 2;
10. Life expectancy = 6 months;
11. Stable or progressive disease, at any stage, in both operable and non-operable patients;
12. Absence of standard treatments already documented and of equal efficacy;
13. No surgical treatment, chemotherapy and/or radiation for at least 30 days. On the other hand, patients in therapy with somatostatin analogues or biological drugs (e.g. m-tor inhibitors) may be considered to be enrolled;
14. Voluntary accession to the study by signing the informed consent form, after reading and complete understanding of the information notes.

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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Lack of the requirements listed above;
2. Pregnancy status;
3. Breastfeeding and its refusal to suspend breastfeeding;
4. Participation in another therapeutic experimental clinical protocol in the four weeks preceding PRRT;
5. Ensured medullary disease invasion > 25%;
6. Extended Radiation treatments (emibody).

Study & Design

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