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Comparator Study of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors

Principal Investigator: M. Sue O'Dorisio, MD

Participants in this research study have been diagnosed with a tumor such as carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells with special proteins called somatostatin receptors.

The purpose of this research study is to see if the tumors can be identified using a special procedure called a positron emission tomography (PET) scan and see if it is as effective as having an Octreoscan and a diagnostic CT. Participants will have an injection with a radioactive drug called 68Gallium-DOTA-tyr3-Octreotide (68Ga-DOTATOC) that binds to tumor cells that have somatostatin receptors and then have a PET scan. A "low dose" computed tomography (CT) scan will then be done on the same scanner. 68Ga-DOTATOC is considered investigational, which means that it has not yet been approved by the U.S. Food and Drug Administration (FDA). The FDA has granted permission to conduct this study under an investigator's new drug (IND) application.

About 112 people will take part in this study conducted by investigators at the University of Iowa.

age group:2 to 99 years trial start date:April 1, 2013
Gender Preference:none Trial End Date: January 1, 2015
Contact Info:

Mary Schall, 319-356-3516

Keywords: brain tumor ; cancer ; carcinoid tumor ; IRB#201212736 ; neuroblastoma ; neuroendocrine tumor ; o'dorisio ; pediatric ; phase 2 ; phase II ; positron emission tomography (PET) scan ; somatostatin receptors ; undefined

Peripheral Vision Study

Individuals 20-70 years of age with no history of eye disease or eye injury are invited to participate in a study evaluating a new method of measuring peripheral vision.

Testing takes 2 to 3 hours. Compensation is provided.

Please contact Tana Wagschal at 467-4540 or tana-wagschal@uiowa.edu for more information.

age group:20 to 70 years trial start date:March 26, 2013
Gender Preference:none Trial End Date: September 26, 2013
Healthy Subject:Yes
Contact Info:

Call Tana Wagschal at 467-4540

Email tana-wagschal@uiowa.edu

Keywords: eye ; peripheral vision

Inflammation Inhibition for Microvascular and Autonomic Dysfunction in Obese Prediabetic Humans (INCITE)

Principal Investigator: Gary L. Pierce, PhD

Non-smoking, men and women age 18-49 years with a body mass index (BMI) of 30 or higher (see BMI calculator http://www.nhlbisupport.com/bmi/ to calculate your BMI) are invited to participate in a research study that will investigate the effectiveness of salsalate, an anti-inflammatory drug similar to aspirin, on blood vessel and nervous system function for 4-weeks in adults with prediabetes (borderline high fasting blood sugar).   Participation will involve blood draws, an oral glucose tolerance test, 24-hour blood pressure monitoring, and assessments of blood vessel and nervous system function in the Institute for Clinical and Translational Science (ICTS) Clinical Research Unit at the University of Iowa.  Participants currently taking medications for Type 2 diabetes are not eligible.

Participants will report to the ICTS Clinical Research Unit up to 7 times over 7-8 week period and must be willing to fast for 8 hours before several of the testing visits.  Participants will be compensated.  

age group:18 to 49 years trial start date:March 12, 2013
Gender Preference:none Trial End Date: January 1, 2014
Healthy Subject:Yes
Contact Info:

Veronica Howsare

veronica-howsare@uiowa.edu

(319) 356-0578

 

Keywords: blood pressure ; blood vessel health ; obese ; prediabetes ; salsalate

A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Previously Untreated, Unresectable, Stage IIIb-IV Melanoma (Amgen protocol #20110264)

Principal Investigator:Mohammed Milhem, MD

Participants in this research study have advanced melanoma. Advanced melanoma means that the tumor is not removable by surgery or has spread to other parts of the body.

The purpose of this research study is to find out more about Talimogene laherparepvec (formerly known as OncoVEXGM-CSF) when given in combination with another drug called ipilimumab.

This study will be conducted in two parts:
 Phase 1 of the study will see if talimogene laherparepvec in combination with ipilimumab is safe for people with advanced melanoma to take.
 Phase 2 of this study will see if talimogene laherparepvec in combination with ipilimumab improves survival and, whether the combination causes any increase in the frequency of side effects. To do this, talimogene laherparepvec in combination with ipilimumab will be compared to ipilimumab alone. Phase 2 will only start after review of information collected during Phase 1.

Approximately 12 people will take part in this study conducted by investigators at the University of Iowa. A total of about 158 people are expected to participate in the study overall, with 18 people in Phase 1 and about 140 people in Phase 2.

age group:18 to 99 years trial start date:March 12, 2013
Gender Preference:none Trial End Date: March 12, 2023
Contact Info:

Melanie Frees, 319-356-1228

Keywords: advanced melanoma ; Amgen #20110264 ; cancer ; ipilimumab ; IRB#201211780 ; melanoma ; milhem ; phase I/II ; phase one ; phase two ; talimogene laherparepvec

Randomized, Phase II Study of MK-3475 versus Chemotherapy in Patients with Advanced Melanoma

Principal Investigator: Mohammed Milhem, MD

Participants in this research sub-study must initially take part in the main research study "Randomized, Phase II Study of MK-3475 versus Chemotherapy in Patients with Advanced Melanoma." The purpose of the substudy is to find out more about what causes disease and the differences in the way people respond to drug therapies. The study consists of providing blood samples, additional biological samples such as left over tumor biopsy or archival tumor tissue samples collected during the main study.

age group:0 to 99 years trial start date:March 8, 2013
Gender Preference:none Trial End Date: March 8, 2023
Contact Info:

Melanie Frees, 319-356-1228

Keywords: cancer ; chemotherapy ; IRB#201208516 ; melanoma ; milhem ; MK-3475 ; pediatric ; phase II ; phase two
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