Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs (REAL-LU)

Advanced Accelerator Applications

Status: Active, not recruiting

Conditions: Gastroenteropancreatic Neuroendocrine Tumor

Treatments: Drug: Lutathera®

Study type: Observational

Funder types: Industry

Identifiers

NCT04727723

CAAA601A0IT02

Details and patient eligibility

About

This is a multicentre long-term non-interventional study of adult subjects diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive GEP-NETs who have been prescribed Lutathera® in standard clinical practice.

Full description

Data on patients will be collected from the date when patient consent was obtained, during treatment with Lutathera® and for a follow-up period until end of study (EOS), defined as the time when the last enrolled patient has completed 36 months of assessments (unless early termination) after enrolment. Data will be collected in accordance with routine clinical visits.

The study duration will be 48 months in total: 12 months recruitment and 36 of follow-up from the last patient in.

Enrollment: 164 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent must be obtained prior to any data collection.
• Patients must be diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic-neuroendocrine tumour (GEP-NET).
• Aged ≥18 years.
• Patients must be naïve to treatment with Lutathera® at enrolment.

Exclusion criteria

• Participation in a current or prior investigational study within 30 days preceding enrolment or within 5 half-lives of the investigational product, whichever is longer.

Trial design

164 participants in 1 patient group

Lutathera®

Description:

Lutathera® will be administered according to the local label and according to the recommended treatment regimen in adults consisting of four equally divided doses of Lutathera® for a total of 29.6 GBq (800 mCi).

Treatment:

Drug: Lutathera®