Clinical Trials

Investigator Initiated Clinical Trials (IRB approved)

The following Investigator Initiated Clinical trials have received IRB approval and the majority of the trials have extramural support.

IRB#22418: FDG-PET/CT in the evaluation of persistent febrile neutropenia in cancer patients. (Hoffman PI)

The specific aim of this Trial is as follows: To perform FDG-PET/CT in approximately 100 in-patients with an absolute neutrophil count (ANC) < 500 cells/mm3, persistent febrile neutropenia (> 5 days) despite broad spectrum IV antibiotics, and the lack of an obvious source of infection. Each suspicious site, identified either by CT alone or by FDG-PET/CT, will be evaluated by directed biopsy and/or culture, whenever possible. Additional confirmatory factors will include clinical response to targeted therapy and resolution of associated radiographic or CT findings. The data will be evaluated to address the following questions, which are the sub-aims of this trial:

  1. How effective is FDG-PET/CT in identifying sites of infection in patients with persistent febrile neutropenia without an obvious cause?
  2. To what degree does FDG-PET/CT improve detection of sites of infection over CT alone?
  3. What FDG-PET/CT imaging variables best predict the presence of infection at a specific site (e.g. standardized uptake value [SUV], concomitant abnormality on CT)?
  4. Can the magnitude of uptake of FDG measured by an SUV at sites of infection predict the identity of the infective agent (bacterial vs. fungal vs. viral)?
  5. Does magnitude of uptake at sites of infection correlate with absolute neutrophil count (ANC)?

IRB#21946: A Multi-modality Imaging Assessment of Chemobrain (Hoffman PI)

To use quantitative FDG-PET, functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as “chemobrain” which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy. The data will be evaluated to address the following questions:

  1. How effective is FDG-PET in identifying differences in regional and global metabolism between the three study cohorts?
  2. To what degree does a FDG-PET regional and global metabolic determination correlate with the severity and focality of cognitive complaints and neuropsychological abnormalities?
  3. Is there a certain pattern of altered metabolism that predicts the presence and severity of cognitive dysfunction?
  4. If there is a known pattern of altered metabolism found in the patient cohort with memory complaints and does this resemble any of the known metabolic patterns seen in Alzheimer’s disease (AD), frontotemporal dementia (FDT), Lewy body disease (LBD), and the Lewy body variant of AD?
  5. Using standard fMRI activation techniques with well tested and validated paradigms to assess pre-frontal connectivity and cortical executive function is there a fundamental difference between the three groups?

IRB#21897: SUTENT® (sunitinib malate) for Metastatic Renal Cell Cancer with Imaging Biomarker Assessments for the Early Prediction of Tumor Response (Hoffman PI)

This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments in 20 patients with metastatic renal cell cancer (RCC) and an early post therapy assessment at baseline and at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients and 4 weeks in 5 patients) after institution of standard approved sunitinib therapy at 37.5 mg/day. The clinical imaging biomarkers will include an assessment of tumor metabolism (dynamic FDG-PET); tumor proliferation (dynamic FLT-PET); tumor blood flow (H215O-PET, DCE MRI); and tumor blood volume (H215O-PET, DCE MRI) in the same patient at baseline and then in the same patient at one of the post therapy time points (1 week, 2 weeks, 3 weeks or 4 weeks).

IRB#26198: Development of an Integrated Molecular Biomarker of Early Prediction of Therapeutic Response to Targeted Therapy in Stage IIIB/IV or Recurrent Lung Cancer Patients using Imaging Assessments and Genomic Modeling (Hoffman PI)

This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments using positron emission tomography (PET) imaging in 21 patients with Stage IIIB/IV or recurrent non-small cell lung cancer (NSCLC) and an early post therapy assessment at baseline and at various early time points (2 weeks in 7 patients, 4 weeks in 7 patients, and 6 weeks in 7 patients) after institution of erlotinib (anti-EGFR) (Tarceva) and bevacizumab (anti-VEGF) (Avastin) for first-line treatment of Stage IIIB/IV or recurrent non-squamous NSCLC.

IRB#31335: Multi-Tracer PET Assessment of Primary Brain Tumors: Pilot Study and Technology Development (Hoffman PI)

This study has two primary objectives: (1) A translational objective in which a new PET imaging technology will be translated from experimental development (with simulations and in animals) to the first use in human subjects; and an exploratory objective in which the complementary value of multiple PET tracers (FDG, FLT, H20 and acetate will be investigated

IRB#00035729: Retrospective analysis of clinical imaging and various testing used in the characterization of dementia (Hoffman PI)

This retrospective study involves a comprehensive chart review and re-analysis of existing clinical dementia data in nearly 300 patients who have undergone a clinical FDG-PET scan to assist in the characterization of their dementia. In this study, we intend to examine whether FDG-PET scans and magnetic resonance imaging (MRI) can influence the final diagnosis and classification of dementias. In addition, we will investigate the utility of different methods of FDG-PET post-processing, when used in combination with MRI, in aiding diagnosis.

IRB#43948: Multi-Tracer PET Assessment of Response in Various Malignancies in Early Phase Therapeutic Clinical Trials (Hoffman PI)

The driving hypothesis for the overall line of research is that multiple PET imaging biomarkers can provide improved image-guided personalized care of patients with various malignancies undergoing early phase therapeutic studies at HCI. This pilot project will obtain initial data on the value of these PET biomarkers for such image-guided personalized care.

Specific hypotheses to be tested include:

  1. Hypothesis I: Dynamic single-scan PET imaging provides biologically relevant functional assessments of effect early in the course of therapy when compared to standard RECIST metrics of response. A composite SUV will be constructed from all the PET tracers applied to each individual. Subjects with <35% decrease in composite SUV with be classified as “progressing by PET”, and subjects with ≥ 35% decrease in composite SUV will be classified as “non-progressing by PET”.
  2. Hypothesis II: Multi-tracer PET biomarkers, obtained in conjunction with a novel therapeutic, are better able to predict tumor aggressiveness than conventional radiographic imaging. This will include better prediction of time to progression (TTP) and patient survival
  3. Hypothesis III: Characterization of multiple aspects of tumor function (glucose metabolism, proliferation, and perfusion) at baseline and after therapy provides new insight into tumor status that can eventually guide selection of the most appropriate therapy.

IRB#00044704: Assessment of Primary and Metastatic Brain Tumor Hypoxia with 18F-Fluoromisonidazole, [18F]fluoro-2-deoxy-D-glucose (FDG) and [15O]water (H215O) (Hoffman PI)

The preliminary efficacy of the radiopharmaceutical 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole, [18F]FMISO, FMISO, a radiopharmaceutical that directly assess tumor hypoxia using Positron Emission Tomography(PET) will be assessed

This preliminary/exploratory clinical study will investigate [F-18]FMISO in 30 evaluable patients with newly diagnosed primary brain tumor or brain metastasis. The primary goal of this study is to determine the association of FMISO PET uptake (hypoxic volume [HV], highest tumor:blood ratio [T/Bmax]), FDG uptake, and tumor blood flow/perfusion determined with H215O and MRI and correlate these variables with overall survival (OS) and time to progression (TTP) in participants with newly diagnosed primary brain tumors or brain metastases.

IRB#52591: Retrospective analysis of patients with history of primary brain neoplasm evaluated with FDG-PET for the presence of recurrent tumor versus tumor necrosis (Hoffman PI)

The objectives of this retrospective study are to:

  1. Examine the previous diagnosis established from electronic medical record, FDG-PET imaging and available follow up imaging (FDG-PET, MRI) which have been obtained to establish the accuracy of the diagnosis. We wish to assess the impact of the various imaging tests on altering a final clinical diagnosis.
  2. Correlate visual assessment of FDG uptake, (SUVmax, and pre-establish cut-off value of 1.8 which accounts to for ratio of metabolic activity of the target lesion to contralateral white matter with progression and survival.
  3. Evaluate the impact of correlating MRI imaging (MR perfusion, MR spectroscopy) where available to the diagnosis of recurrent tumor versus tumor necrosis.

IRB#60947: Preliminary Assessment of [18F] Fluciclatide (GE [18F]AH111585) in Glioblastoma Multiforme Treated with Bevacizumab

This exploratory study uses [18F] Fluciclatide (10 mCi) an investigational PET imaging agent and PET imaging in patients with glioblastoma multiforme (GBM) to be treated with Bevacizumab. The primary objective of this study is to determine the safety and preliminary efficacy of [18F] Fluciclatide in patients with GBM receiving standard Bevacizumab therapy (10mg/kg IV every 2 weeks). Secondary exploratory objectives are to determine the association of [18F] Fluciclatide uptake, FDG uptake, and tumor blood flow/perfusion determined with H215O and MRI and correlate these variables with time to progression (TTP) in participants with GBM treated with Bevacizumab.

IRB#68059: Investigation of the Roles of Inflammation and Cancer in the Development of Dementia and Other Cognitive Deficits

The primary objective of this study is to determine the association of inflammation and cancer in the development of dementia and other cognitive deficits. The study addresses the following four aims:

Aim 1: Test hypotheses that inflammatory disease diagnosis will be associated with an increased risk of dementia and other cognitive deficits.

Aim 2: Test hypotheses that treatments to suppress the immune system, such as in the case of solid organ transplants, will be associated with a decreased risk of dementia and other cognitive deficits.

Aim 3: Test hypotheses that cancer diagnosis will be associated with an increased risk of dementia and other cognitive deficits.

Aim 4: Explore whether or not the two-hit hypothesis (i.e. diagnosis of both cancer and an inflammatory disease) will substantially increase the likelihood of developing dementia and other cognitive deficits.

Contact Us

Center for Quantitative Cancer Imaging Director
John M. Hoffman, MD


HCI Senior Director Oversight
Cornelia Ulrich, MS, PhD

Faculty Advisory Committee Chair
David Goldgar, PhD

Faculty Advisory Committee Members
Lisa Aspinwall, PhD
Saundra Buys, MD
Matthew Firpo, PhD
Kimberly Kaphingst, PhD
Deborah Neklason, PhD
Erin Rothwell, MS, PhD
Joshua Schiffman, MD
Theresa Werner, MD