Clinical Research
ACRIN Affiliation
Over the past twenty years, Clinical Radiologists (CR) has participated in the American College of Radiology Imaging Network (ACRIN) multi-center clinical trials. ECOG-ACRIN is a cooperative research group under the aegis of the National Cancer Institute. Through National Cancer Institute grant monies, ECOG-ACRIN has directed a number of large-scale imaging studies focusing on cancer patients. These studies include screening, imaging, image guided, and interventional procedures.
To date, Clinical Radiologists has participated in the following ACRIN and ECOG-ACRIN trials:
- Protocol #6651: Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer. This study compared FIGO staging to pretreatment staging by CT and MRI for patients with FIGO stage 1B1, 1B2, and IIA who are scheduled for surgery. Accrual for this study is complete and results have been published.
- Protocol #6664: National CT Colonography Trial. This study was developed to evaluate the sensitivity of CT colonography for detecting participants with at least one proved clinically significant large lesion using colonoscopy as the reference standard. Accrual for this study began March 1, 2005 and is complete. Results have been published in the New England Journal of Medicine.
- Protocol #6667: MRI Evaluation of the Contralateral Breast in Women with a Recent Diagnosis of Breast Cancer. The primary aim of this study is to assess the diagnostic yield of MRI in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam. Accrual for this study is complete and results have been published in the New England Journal of Medicine.
- Protocol #6685: A multicenter trial of FDG-PET/CT staging of head and neck cancer and its impact on the N (0) surgical treatment in head and neck cancer patients.
- Protocol #7151: Incidence and Signficance of Extracolonic Findings on CT Colonography: Retrospective analysis of National CT Colonography Trial data.
- Protocol EA 1141: Comparison of Abbreviated Breast MRI and Digital Breast Tomosynthesis in Breast Cancer Screening. (currently active)
Pharmaceutical Trials
CR has also participated in many industrial trials. These trials include the following:
- Phase II study of IV Tc-capromab in patients with proven prostate cancer soft tissue metastasis
- Tc99m Leutech Scintigraphy for the detection of appendicitis in patients with equivocal symptoms
- Economic analysis of Tc99m LeuTech Scintigraphy for the detection of appendicitis
- ETc99m Leutech scintigraphy for the detection of osteomyelitis in diabetic foot ulcer patients
- Tc99m Leutech scintigraphy for the detection of abscess in post-surgical patients
- Dosimetry study of Tc99m Leutech scintigraphy in pediatric patients
- Comparison of CR Digital Breast Images and Screen-Film Images for Specimens
- Bracco Diagnostics MH 136: A Prospective Cohort Study Evaluating the Incidence of nephrogenic systemic fibrosis (NSF) in Patients with Stage 3 to 5 Chronic Kidney Disease undergoing MRI with injection of Multihance.
- Bayer Gemma 91743: An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1.0 molar (Gadovist®) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI.
- Bracco PH-107: A Phase IV, double blind, multicenter, randomized, crossover study to compare 0.1mmol/kg of Prohance with 0.1 mmol/kg of Gadovist/Gadavist in magnetic resonance imaging of the brain.
- Bracco MH 148: A Phase IV, double blind, multicenter, randomized, two-arm crossover study to compare .01mmol/kg of Multihance with 0.1mmol/kg of Dotarem and 0.05mmol/kg of Multihance with 0.1 mmol/kg of Dotarem in magnetic resonance imaging (MRI) of the Brain (Benefit) (currently active)
- Pneumbra CARE: A multicenter case study to assess radiation exposure in patients treated with the Pneumbra Coil 400. (currently active)
- Pneumbra SMART: A prospective multi-center registry assessing the embolization of neurovascular lesions using the Penumbra SMART COIL System. (currently active)
Cooperative Group Research
- Alliance AO11104: Effect of preoperative breast MRI for surgical outcomes, costs and quality of life of women with breast cancer. (currently active)
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