Overview

Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy

Status:
Not yet recruiting

Trial end date:
2024-12-01

Target enrollment:
0

Participant gender:
All

Summary

Randomised trial to assess progression of carcinoid heart disease in patients treated with Lutathera therapy compared to best supportive care.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

King's College Hospital NHS Trust

Collaborator:

Advanced Accelerator Applications

Treatments:

Lutetium Lu 177 dotatate

Criteria

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