UnknownPhase 2

Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy

20 participantsStarted 2020-10

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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®).

The rate of progression of moderate carcinoid heart disease (CHD)

Timeframe: 5 years

NCT IDNCT04039516

SponsorKing's College Hospital NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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®).