CLINICAL TRIALS PROFILE FOR INDIUM IN-111 PENTETREOTIDE KIT

All Clinical Trials for indium in-111 pentetreotide kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001849 ↗	New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1999-05-20	Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol. Cortisol is produced in the adrenal gland as a response to the production of corticotropin (ACTH) in the pituitary gland. Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectopic production of the hormone ACTH. Meaning, the hormone is not being released from the normal site, the pituitary gland. In many cases the ectopic ACTH is being produced by a tumor of the lung, thymus, or pancreas. However, in approximately 50% of these patients the source of the ACTH cannot be found even with the use of extensive imaging studies such as computed tomography (CT) scans, magnetic resonance imaging (MRI), and nuclear scans (111-indium pentetreotide). The ability of these tests to locate the source of the hormone production is dependent on the changes of anatomy and / or the dose and adequate uptake of the radioactive agent. The inability to detect the source of ectopic ACTH production often results in unnecessary pituitary surgery or irradiation. Unlike the previously described tests, positron emission tomography (PET scan) has the ability to detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This study will test whether fluorine-18-fluorodeoxyglucose (FDG), fluorine-18-dihydroxyphenylalanine (F-DOPA) or use of a higher dose of 111-indium pentetreotide can be used to successfully localize the source of ectopic ACTH production.
NCT00442533 ↗	Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors	Completed	CHI St. Luke's Health, Texas	Phase 2/Phase 3	2005-08-01	The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
NCT00442533 ↗	Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors	Completed	Excel Diagnostic Imaging Clinics	Phase 2/Phase 3	2005-08-01	The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
NCT00442533 ↗	Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors	Completed	RadioMedix	Phase 2/Phase 3	2005-08-01	The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
NCT00442533 ↗	Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors	Completed	Radiomedix, Inc.	Phase 2/Phase 3	2005-08-01	The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
NCT00442533 ↗	Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors	Completed	Radio Isotope Therapy of America	Phase 2/Phase 3	2005-08-01	The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
NCT01619865 ↗	Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors	Completed	Sue O'Dorisio	Phase 1/Phase 2	2012-02-21	This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.

Clinical Trial Conditions for indium in-111 pentetreotide kit

Condition Name

Condition Name for indium in-111 pentetreotide kit
Intervention	Trials
Cushing Syndrome	2
Neuroendocrine Tumors	2
ACTH	1
Carcinoid Tumors	1

Condition MeSH

Condition MeSH for indium in-111 pentetreotide kit
Intervention	Trials
Neuroendocrine Tumors	3
Carcinoid Tumor	3
Cushing Syndrome	2
Cardiac Complexes, Premature	2

Clinical Trial Locations for indium in-111 pentetreotide kit

Trials by Country

Trials by Country for indium in-111 pentetreotide kit
Location	Trials
United States	4
Switzerland	1

Trials by US State

Trials by US State for indium in-111 pentetreotide kit
Location	Trials
Maryland	2
Iowa	1
Texas	1

Clinical Trial Progress for indium in-111 pentetreotide kit

Clinical Trial Phase

Clinical Trial Phase for indium in-111 pentetreotide kit
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 2	2
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for indium in-111 pentetreotide kit
Clinical Trial Phase	Trials
Completed	3
Terminated	1
Recruiting	1

Clinical Trial Sponsors for indium in-111 pentetreotide kit

Sponsor Name

Sponsor Name for indium in-111 pentetreotide kit
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1
SWAN Isotopen AG, Bern	1

Sponsor Type

Sponsor Type for indium in-111 pentetreotide kit
Sponsor	Trials
Other	10
NIH	3
Industry	2