Status:
UNKNOWN
Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy
Lead Sponsor:
King's College Hospital NHS Trust
Collaborating Sponsors:
Advanced Accelerator Applications
Conditions:
Carcinoid Heart Disease
Carcinoid Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Randomised trial to assess progression of carcinoid heart disease in patients treated with Lutathera therapy compared to best supportive care.
Detailed Description
This is an open-label, phase II, multicentre, randomised (1:1) clinical trial of an interventional medicinal product. This study will open at 3 centres across the UK. King's College Hospital NHS Found...
Eligibility Criteria
Inclusion
- Echocardiographic evidence of mild/ moderate carcinoid heart disease.
- Carcinoid syndrome with Echocardiographic evidence of carcinoid heart disease- to be defined further
- Elevated urinary 5-HIAA or NYHA class I or II on therapy \[not necessarily exceeding label dose of SSA LAR; eg, could be 30mg SMS LAR plus sc SMS for breakthrough\]
- Presence of metastasized or locally advanced, inoperable (curative intent) histologically proven, Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine (GEP-NET) or Lung-NET tumor
- Age \>18
- Ki67 index ≤ 20%
- Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related activities
- Confirmed presence of somatostatin receptors on all target lesions documented by CT/MRI scans, within 8 weeks prior to randomization (centrally confirmed), as assessed by the following somatostatin receptor imaging (SRI) modalities: \[68Ga\]-DOTA-TOC (Somakit-TOC™) PET/CT imaging or \[68Ga\]-DOTA-TATE PET/CT imaging (NETSPOTTM) or Somatostatin Receptor scintigraphy (SRS) with 111In-pentetreotide (Octreoscan®).
- 10\. Irresectable disease 11. Karnofsky Performance Score (KPS) ≥60.
Exclusion
- Patients with progressive disease by RECIST progressed within 6 months
- Unable to consent
- Pregnant
- Chemotherapy within 3 months
- PRRT within 3 years
- Grade 3 tumours (WHO 2010)
- Severe or Uncontrolled carcinoid heart disease
- Renal impairment with eGRF \<40 ml/min
- NYHA class III,IV
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04039516
Start Date
October 1 2020
End Date
December 1 2024
Last Update
August 4 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.