First Name Matthew Middle Initial J Last Name Goette Degree PhD Address 6701 Fannin Street Suite 470 Houston, TX 77030 United States Phone Number (832) 822-1356 Fax (832) 825-0300 Email mjgoette@texaschildrens.org Upload Cover Letter goette_pilot_coverletter.pdf 69.15 KB · PDF Investigator/Applican Matthew t First Name Investigator/Applican J t Name MI Investigator/Applican Goette t Last Name Investigator/Applican PhD t Degree Investigator/Applican t Name Address 6701 Fannin Street Suite 470 Houston, TX 77030 United States Investigator/Applican (832) 822-1356 t Name Phone Number Investigator/Applican mjgoette@texaschildrens.org t Name Email Title Integrated PET/MR in Pediatric Hodgkin Lymphoma Abstract of Proposed Research Plan (300 words) The overall goal of our prospective research project is to compare the diagnostic and prognostic efficacy of standard 18F-FDG PET/CT to alternative radiation-sparing imaging strategies including novel integrated 18F-FDG PET/MR and diffusion weighted (DW) MR scans in pediatric patients with Hodgkin lymphoma. 18F-FDG PET/CT has been established for staging of most types of malignant lymphoma in pediatric patients, but 18F-FDG PET/CT staging tests have been associated with risk of secondary cancer development later in life, especially for pediatric patients. Recently, integrated 18F-FDG PET/MR and diffusion-weighted MRI (DW MR) imaging have been shown to provide tumor staging with markedly reduced radiation exposure compared to PET/CT. While these new imaging modalities show a comparable diagnostic accuracy to 18F-FDG PET/CT for lymphoma staging, it is not known whether the imaging test can also accurately diagnose tumor therapy response. We prop ose to address the urgent need of a systematic evaluation of these new imaging tests, in order to define the most accurate and safe “onestop-shop” imaging approach for staging and re-staging of Hodgkin lymphoma in pediatric patients. This will be accomplished in a prospective non-randomized clinical study of pediatric patients with Hodgkin lymphoma. The proposed imaging technologies could solve the need for balancing critical diagnostic testing for tumor assessment with concurrent risk of radiation-induced secondary cancer development later in life. This one-stop-shop approach to oncologic staging and response assessment using integrated PET/MRI has the potential to lead to improved diagnostic efficacy, consistency, cost savings, reduced need for sedation, and reduced radiation exposure. Results of this project will have immense significance for the care of our pediatric oncology patients by defining the most accurate staging and re-staging exam, saving a large patient population from excessive radiation exposure associated with diagnostic testing, and decreasing associated risks of potential long-term secondary tumor development later in life. Upload: Detailed plan and bibliography goette_pilot_detailed_plan.pdf 334.52 KB · PDF Resources and Environment: Texas Children’s Hospital Department of Pediatric Radiology: Texas Children's Hospital (TCH), licensed for 639 beds, is the nation's largest pediatric hospital. Its physicians treat infants, children, and adolescents, and its units specialize in the diagnosis and treatment of rare disorders. Almost all of the geographically-based physicians at the hospital are members of the full-time faculty of Baylor. More than 42 medical and surgical outpatient services are available. Based on the most recent U.S. News & World Report, Texas Children’s Hospital is one of only eight hospitals to achieve Honor Roll status and ranks near the top in all of the subspecialty categories. The comprehensive survey – the most extensive listing of its kind – ranks children’s hospitals across ten major subspecialties. Texas Children’s was named as a best hospital in every subspecialty surveyed, and was ranked in the top ten in nine out of ten categories. In earning its position on the Honor Roll, Texas Children’s Hospital was ranked among America’s best in: Kidney Disorders (4); Respiratory Disorders (4); Heart and Heart Surgery (3); Cancer (5); Digestive Disorders (4); Neurology and Neurosurgery (4); Neonatal Care (7); Diabetes and Endocrine Disorders (10); Urology (9); and Orthopedics (12). With Baylor, Texas Children's participates in approximately 400 research projects and receives more NIH research funding than any other pediatric hospital in the nation. Current projects include testing of medications to improve the quality of life for patients with HIV infection and AIDS, diagnostic methods based on DNA analysis for cystic fibrosis, muscular dystrophy and other genetic disorders, and development of treatments through human gene therapy and other basic and applied research studies. The two institutions operate the nation's first Children's Nutrition Research Center, a U.S. Department of Agriculture facility that conducts research on the nutritional needs of pregnant and nursing women and their children. Investigators at the CNRC are all BCM faculty. TCH Pavilion for Women: Expanding upon its premier reputation in fetal and neonatal medicine, TCH opened the Pavilion for Women in November 2011 to provide a full continuum of family-centered care to women, mothers, and their babies, beginning before conception and continuing after birth through all the years of a woman's life. The Pavilion for Women responds to the escalating need for obstetrical research and treatment and will ensure that mothers and their babies have access to the most advanced technologies and treatments available. What makes this facility unique is the full range of obstetrical and gynecological services that are all available in one location, including evaluation and consultation, preterm birth evaluation, as well as perinatal diagnostic and treatment services and support, childbirth and parenting classes, lactation support and psychosocial support services. This is coupled with Texas Children’s expertise in pediatric subspecialty care, inclu ding targeted programs in high-risk obstetrics, fetal intervention and surgery, multiple pregnancy (with a dedicated unique “Program for Multiples”), fetal echocardiography, reproductive endocrinology, and neonatal intensive care. The 15-story, 790,000square-foot facility has 90 patient beds with the capacity for more than 5,000 births per year; it also houses both a Level II and Level III Neonatal Intensive Care Unit with private rooms for families to stay together while the infant receives care. These NICUs have a combined capacity for over 2,000 infants per year. A skybridge connects the Pavilion to the main TCH facility to allow rapid access to additional specialized care. The following relevant clinical services are offered in the Pavilion. TCH Feigin Research Center: With its Vision 2010 campaign, TCH launched several projects to strengthen innovative patient care and invest in new translational research. Its major research center, the Feigin Center, houses 20 floors and half-a-million square feet of lab space that accommodates more than 120 investigators (all BCM faculty) and all the Core facilities needed to image, store, and test biologic, genetic, and clinical samples of all kinds. The Feigin Center expansion, which concluded in 2008, allows researchers to intensify their research in areas of fundamental importance in microbiology, immunology, cell biology and sciences of infection and inflammation. The Texas Medical Center: Baylor College of Medicine provides the fulcrum for the Texas Medical Center (TMC) at Houston. It is the largest medical center in the world with 14 hospitals, two specialty institutions, two level 1 trauma centers, three medical schools, six nursing schools, schools of dentistry, public health, pharmacy and nearly all health related careers. TMC pioneered the first and still the largest air ambulance service. Today there are a total of 54 institutions (26 government agencies and 26 private not-for-profit health related institutions) in the TMC. There are 7.1 million annual patient visits and 92,500 employees, 34,000 students and 4,000 residents and fellows. There are 280 buildings on 1,300 acres of land. Hospitals Affiliated with Baylor College of Medicine: The educational and research programs at BCM are highly integrated and amplified through strong affiliations with private and public teaching hospitals. The school has its own private adult outpatient facility, the Baylor Clinic, designed to provide the highest quality of care and service in an environment that promotes translational research. BCM has an international reputation for medical excellence and has long had affiliations with a number of different Texas Medical Center hospitals. It is ranked as one of the top 20 medical schools for research in US News and World Report and is 1st in Texas in NIH funding. There are 8 affiliated teaching hospitals: St. Luke’s Episcopal Hospital, Texas Children’s Hospital, Memorial Herman's The Institute for Rehabilitation and Research, The Menniger Clinic, The Methodist Hospital, Michael E. DeBakey Veterans Affairs Medical Center, M.D. Anderson Cancer Center, and th e Ben Taub General Hospital, part of the Harris Health System. There are an additional 12 cooperating Patient Care Institutions. Major Equipment: Major equipment in the clinical pediatric radiology imaging suite include: 1. Philips Ingenuity TF PET/MR Scanner 2. Philips Ingenuity TF PET/CT Scanner Other equipment in the Imaging Facility is as follows: 1. Siemens Inveon micro-CT/SPECT-micro-PET integrated system small animal imaging system. 2. Aspect M2 1T horizontal bore small animal MRI scanner for low-field imaging in rodents. 3. Bruker 9.4 T BioSpec horizontal bore MRI scanner for performing magnetic resonance and spectroscopy studies in rodents 4. Xenogen IVIS 100 imaging system for in vitro and in vivo bioluminescence imaging 5. VisualSonics Vevo 770 high frequency, high spatial resolution ultrasound system for in vivo imaging 6. Nikon intravital microscope for bright field and fluorescent in vivo imaging 7. Cyclone Plus Phosphor Scanner for high resolution, quantitative digitized phosphor scanning for autoradiography 8. 2470 Wizard Automatic Gamma Counter equipped with 51 radionuclide energy window library for running 550 samples 9. Leica microscope capable of bright field and fluorescent imaging equipped with a motorized XY stage, monochrome CCD camera Computational resources: 1. 32-core HP Z-800 workstation running Linux, Matlab 2. 8-core HP Z-400 computers running Windows and Linux (dual boot) All personnel have personal workstations as well. Other key computational resources are as follows: 1. Intel Xeon 64-bit Vitrea workstation (v 6.1) with advanced image processing/visualization for clinical and pre-clinical research – features include Vessel Probe, Cardiac Functional Analysis, Cardiac Calcium Analysis, SUREPlaque etc. 2. MacPro Xeon dual-core workstation for image processing/analysis (loaded with 64-bit Osirix) 3. 4T image repository with secure FTP access 4. Dell Optiplex 745 computers (x4) 5. Printers, scanners 6. Integrated storage back up (Texas Children’s Hospital) Additional In addition to the principal investigator who is a dedicated PET/MRI physicist, the Information: study mentor, one of two board-certified nuclear medicine radiologists assigned to this study (among ~25 board-certified pediatric radiologists on staff in the department), and the co-investigator who is a dedicated research statistician, the TCH pediatric radiology department contains experienced research project coordinators and support staff including imaging technicians specifically trained in PET/MR acquisition. Award Payee First Leanne Name Award Payee Middle Initial B Award Payee Last Scott Name Award Payee PhD Degree Award Payee Address One Baylor Plaza Suite 600D Houston, TX 77030-3411 United States Award Payee Phone (713) 798-1297 Number Award Payee Email spo@bcm.edu Grant Administrator's Shireen First Name Grant Administrator's E MI Grant Administrator's Hayatghaibi Last Name Grant Administrator's MS Degree Grant Administrator's Address 6701 Fannin Street Suite 470 Houston, TX 77030 United States Grant Administrator's (832) 822-1225 Phone Number Grant Administrator's Email sehayatg@texaschildrens.org Upload Letters of Recommendation 1 spr_grant_matt_g_03_11_15.pdf 327.85 KB · PDF Upload Letter of Recommendation 2 goette_recommendation_letter__krishnamurthy.pdf 37.83 KB · PDF Upload Budget goette_pilot_budget.pdf 123.76 KB · PDF Upload Curriculum Vitae goette_pilot_cv.pdf 104.36 KB · PDF (Upload) Mentor/CoInvestigators goette_pilot_mentor_biosketch_seghers.pdf 65.10 KB · PDF Upload Research Assurances h32322__evaluation_of_clinical_equivalence_of_pet_ct_and_pet_mri_in_children.pd f 138.73 KB · PDF