Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Thyroid Cancer, Medullary

All Drugs and Chemicals

Bone Density Conservation Agents

Vasodilator Agents

Gastrointestinal Agents

Antihypertensive Agents

Sacubitril and valsartan sodium hydrate drug combination

Calcitonin

Salmon calcitonin

Calcitonin Gene-Related Peptide

Katacalcin

Gastrins

Cholecystokinin

Valsartan

Angiotensin Receptor Antagonists

First intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N without and second injection with additional medication of Sacuitril (100 mg Entresto)(crossover)

First intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and second injection without additional medication of Sacuitril (100 mg Entresto)(crossover)

Intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without co-medication with Sacuitril (100 mg Entresto) in each patient

177Lu-PP-F11N

Medication with Sacuitril (100 mg Entresto) additional to the injection of 177Lu-PP-F11N

Sacuitril

Christof Rottenburger, Dr. med.

Damian Wild, PhD Dr

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.

A phase 0 study (Lumed study part A) was already performed, showing low toxicity of 177Lu-PP-F11N and tumor uptake in all patients. Co-injection of Physiogel (Gelofusin) showed insignificant reduction of kidney uptake and can therefore be omitted for a radionuclide therapy with 177Lu-PP-F11N. In this study, the effect of the NEP-1 inhibitor Sacuitril on the in-vivo stability of 177Lu-PP-F11N and the uptake, respectively radiation doses in MTC metastases and organs will be evaluated, using a cross-over design already used for the Lumed part A study. Each patient will receive two injections of 177Lu-PP-F11N, with and without additional medication with Sacuitril Imaging findings, acquired by SPECT/CT, will be compared to imaging with 68Ga-DOTATOC positron emission tomography (PET)/CT. The inclusion of 8 patients is planned.

Group 1 patients will receive first 177Lu-PP-F11N alone, second 177Lu-PP-F11N in combination with Sacuitril. Group 2 patients will first receive 177Lu-PP-F11N in combination with Sacuitril, second 177Lu-PP-F11N alone. Affiliation of patients to Groups 1 and 2 will be randomised.

177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer

177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer (Lumed Phase 0/B)

Chromogranin A blood values will be compared to the radiation doses of the stomach.

Comparison of tumor imaging by 68Ga-DOTATOC PET/CT and 177Lu-PP-F11N SPECT/CT

Evaluation of the radiation doses in tumor tissue from MTC after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)

Evaluation of the radiation doses in the kidneys and the tumor-to-kidney dose ratios after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)

Evaluation of the radiation doses in other organs and the appropriate organ-to-kidney dose ratios after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)

Measurement (HPLC) of the in-vivo stability of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto).

In case of surgery with available tumor tissue samples, imaging results will be compared with autoradiographic analysis of somatostatine- and CCK2-receptor expression in tumor tissue.

Krebsforschung Schweiz, Bern, Switzerland

Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland

University Hospital, Zürich

University Hospital Freiburg

University Hospital, Basel, Switzerland

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Lung Neoplasms

Neuroendocrine Tumors

Thymoma

Thymus Neoplasms

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neuroendocrine Tumor

Neuroepithelioma

Hormones

Hormone Antagonists

Phase 0: 6 patients, intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without Physiogel (crossover)

Phase I: expected 12 - 18 patients, intravenous application of max. 6 x 7-8 GBq 177Lu-PP-F11N (increasing number of applications by one in groups of three patients). All patients with or without Physiogel, depending on the results of the phase 0 study.

Damian Wild, Prof Dr Dr

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.

In the pilot (phase 0) study investigators will correlate the tumour detection rate with the surgery and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will be performed in order to determine the kidney protection protocol and starting activity for the dose escalation study in the following, dose escalation (phase I) study. In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well as organ radiation doses and maximal tolerated dose will be performed in order to allow prospective individual patient tailored therapy planning. In the phase I study, participation is additionally possible for patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2).

177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.

177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.

Phase 0 study: Evaluation of the scintigraphic visualisation of metastases after test injection, verification of 177Lu-PP-F11N uptake in metastases and correlation with surgery/histology if possible (poof of principle study).

Phase I study: Determination of the maximum tolerated dose (MTD)

Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure.

Calculation of tumour and organ radiation doses.

Evaluation of in vivo stability of 177Lu-PP-F11N.

Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.

Evaluation of side reactions of 177Lu-PP-F11N.

Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time).

Evaluation of morphological therapy response (RECIST criteria).

Determination of the tumour detection rate and correlation with surgery/histology, if possible.

Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure).

Determination of overall survival of patients after therapy.

Measurement of the metabolites of 177Lu-PP-F11N.

Digestive System Diseases

Gastroesophageal Reflux

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Patients will take 25 mg YF476 once daily for 12 weeks

Patients will take matching placebo once daily for 12 weeks

YF476

YF476 placebo

Julian A Abrams, MD MS

A phase 2, randomised, double-blind, out-patient trial to determine if YF476 is a safe and effective treatment in patients with Barrett's esophagus.

YF476 in Barrett's Esophagus

Randomized, Placebo-controlled Trial of YF476, a Gastrin Receptor Antagonist, in Barrett's Esophagus

Esophagogastroduodenoscopy (EGD) was performed to enable taking biopsies for assessment of Ki67 expression, a marker of cellular proliferation. Ki67 expression was assessed by immunohistochemistry and calculating the number of Ki67 positive cells per mm\^2 of Barrett's epithelium.

Blood samples were taken for assay of biomarkers associated with esophageal adenocarcinoma. Changes in biomarker expression were derived from RNA-Sequencing and calculated as log-fold change comparing the treatment group to the placebo group. The nature of how results are derived by RNA-sequencing means summary statistics cannot be generated individually for each arm and a value has not been calculated for each individual participant. Therefore, results are reported as the relative change in biomarker expression in the treatment arm compared to the placebo arm.

Blood samples were taken to assess the effects of YF476 on fasting serum gastrin, a marker of gastric acid suppression

Blood samples were taken to assess the effects of YF476 on fasting plasma CgA, a marker of ECL cell hyperplasia

Columbia University

University of Cambridge

Trio Medicines Ltd.

Any untoward medical occurrence in a study participant that does not necessarily have a causal relationship with the treatment

Patients will take 25 mg YF476 once daily for 12 weeks

YF476: gastrin receptor antagonist

Treatment

Patients will take matching placebo once daily for 12 weeks

YF476 placebo: placebo

YF476 Placebo

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

United Kingdom

Region of Enrollment

Ki67 expression

Fasting serum gastrin concentration (marker of gastric acid suppression)

Fasting plasma CgA concentration (marker of ECL cell hyperplasia)

Dr Malcolm Boyce

Baseline

Week 12

3 patients in the treatment arm and 1 patient in the placebo arm were withdrawn from the study due to reasons unrelated to the treatment. Therefore, Week 12 data show results from 10 patients per arm.

Change in Ki67 Biomarker Expression

CCK2R, Week 12

PTGS2, Week 12

DCLK1, Week 12

3 patients in the treatment arm were withdrawn from the study due to reasons unrelated to the treatment. Therefore, results are reported for 10 patients.

Expression of Biomarkers Potentially Associated With Esophageal Adenocarcinoma (EAC)

Week 4

Week 6

Week 8

Follow-up

After 6 patients (3 per treatment) had their Week 4 and 8 visits, the protocol was amended so that those visits were replaced by a single visit at Week 6 in order to reduce the total number of visits.

Abundance of Biomarkers of Gastric Acid Suppression

Abundance of Biomarkers of ECL Cell Hyperplasia

Overall Study

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Stomach Diseases

Stomach Cancer

Antibodies

Immunoglobulins

Immunoglobulin G

PG negative （pepsinogen（PG）Ⅰ \> 70ng/ml or PGⅠ/PGⅡ \>7.0）and Hp (helicobacter pylori) negative. A questionnaire survey are accomplished in 40-70 years old candidates. Eligible subjects are detected PG I and II, Hp-IgG antibody through serological examination. Gastroscope also accomplished in all participants.

PG negative and Hp positive. A questionnaire survey are accomplished in 40-70 years old candidates. Eligible subjects are detected PG I and II, Hp-IgG antibody through serological examination. Gastroscope also accomplished in all participants.

PG positive (PGⅠ ≤ 70ng/ml and PGⅠ/PGⅡ≤7.0) and Hp negative. A questionnaire survey are accomplished in 40-70 years old candidates. Eligible subjects are detected PG I and II, Hp-IgG antibody through serological examination. Gastroscope also accomplished in all participants.

PG positive and Hp positive. A questionnaire survey are accomplished in 40-70 years old candidates. Eligible subjects are detected PG I and II, Hp-IgG antibody through serological examination. Gastroscope also accomplished in all participants.

serological examination and gastroscope

The purpose of this study is to determine whether detection of pepsinogen Ⅰand Ⅱ combined with Helicobacter pylori antibody, so-called ABC method , is fit on gastric cancer screening in community of Wuxi City.

Gastric cancer is the third largest cause of cancer related deaths in China with about 350 ,000 gastric cancer-related deaths by gastric cancer in 2012. The studies from Japan and Korea have found gastric cancer screening, especially of the mass population, reduces mortality from gastric cancer, but the data is seldom in China. The ways include radiographic and endoscopic screening, although those methods were shown to reduce gastric cancer mortality, and was recommended as gold standard for population-based screening by Japan and Korea, but many problems have been pointed out: A serious drawback is low uptake of the target population; fear for radiation exposure(0.6 mSv), swallowing unpleasantness due to the use of barium meal, accidental fall during the examination and constipation, causing rare but more serious complications such as intestinal obstruction or diverticulitis after examination may account for the reasons for this low uptake, endoscopic screening is labor-intensive, more costly per examination as complete disinfection of the scope is mandatory, and requires a large number of well-trained experienced endoscopists.

Serological method, so-called ABC method , has been useful as gastric cancer preliminary screening in some areas, such as China, Japan and Korea. The major reasons are attributed to its simplicity, safety (radiation-free, discomfort free), and cost-efficiency. The ABC method is a blood test to stratify the risk of gastric cancer using the combination of H. pylori antibody and pepsinogen I and II, that was documented by large-scale studies in Japan. But the data was short in China, especially in the community.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer	NCT03647657	Thyroid Cancer,...	177Lu-PP-F11N Sacuitril	18 Years - 64 Years	University Hospital, Basel, Switzerland
177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer	NCT03647657	Thyroid Cancer,...	177Lu-PP-F11N Sacuitril	18 Years - 64 Years	University Hospital, Basel, Switzerland
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.	NCT02088645	Thyroid Cancer,... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ...	177Lu-PP-F11N	18 Years -	University Hospital, Basel, Switzerland
YF476 in Barrett's Esophagus	NCT02597712	Barrett's Esoph...	YF476 YF476 placebo	18 Years -	Trio Medicines Ltd.
Serological Screening of Gastric Cancer in Wuxi Region	NCT02663427	Stomach Neoplas...	serological exa...	40 Years - 70 Years	Wuxi People's Hospital

Spots Global Cancer Trial Database for gastrin

Every month we try and update this database with for gastrin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gastrin

Every month we try and update this database with for gastrin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gastrin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.