Clinical trial · Interventional
Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy
Phase II Randomised Trial to Assess Progression of Carcinoid Heart Disease in Patients Treated With Lutathera Therapy Compared to Best Supportive Care.
NCT04039516CI-TRIAL-00046417CHARRTunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomised trial to assess progression of carcinoid heart disease in patients treated with Lutathera therapy compared to best supportive care.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoid Heart Disease | — | UNRESOLVED | — |
| Carcinoid Syndrome | — | UNRESOLVED | — |
| Carcinoid Tumor | Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lutathera | Drug | Lutetium (177lu) Oxodotreotide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lutathera Treatment Arm
- description
- • 4x cycles of 7.4 GBq (200mCi) of Lutathera therapy (177Lu-DOTA0-Tyr3-Octreotate) with concomitant amino acids for participants randomised onto the Lutathera therapy arm, every 8 weeks, plus long term somatostatin analogues (SSTA).
- interventionNames
- Drug: Lutathera
- type
- NO_INTERVENTION
- label
- Best Supportive Care
- description
- Somatostatin analogue treatment according to current standard, routine care
Primary outcomes (1)
- measure
- The rate of progression of moderate carcinoid heart disease (CHD)
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Echocardiographic evidence of mild/ moderate carcinoid heart disease. 2. Carcinoid syndrome with Echocardiographic evidence of carcinoid heart disease- to be defined further 3. Elevated urinary 5-HIAA or NYHA class I or II on therapy \[not necessarily exceeding label dose of SSA LAR; eg, could be 30mg SMS LAR plus sc SMS for breakthrough\] 4. Presence of metastasized or locally advanced, inoperable (curative intent) histologically proven, Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine (GEP-NET) or Lung-NET tumor 5. Age \>18 6. Ki67 index ≤ 20% 7. Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related activities 8. 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 Criteria: 1. Patients with progressive disease by RECIST progressed within 6 months 2. Unable to consent 3. Pregnant 4. Chemotherapy within 3 months 5. PRRT within 3 years 6. Grade 3 tumours (WHO 2010) 7. Severe or Uncontrolled carcinoid heart disease 8. Renal impairment with eGRF \<40 ml/min 9. NYHA class III,IV
References
Publications (0)
Data not yet available
No reference posted for this study.