Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients with Head and Neck Cancer
Phase I
Phase I
This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon emission computed tomography (SPECT)/computed tomography (CT) and panitumumab-IRDye800 fluorescence imaging during surgery (intraoperative), to detect disease in patients with head and neck cancer. 111In-panitumumab is an imaging agent made of a monoclonal antibody that has been labeled with a radioactive molecule called indium In 111. The agent targets and binds to receptors on tumor cells. This allows the cells to be visualized and assessed with SPECT/CT imaging techniques. SPECT is special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. CT is an imaging technique for examining structures within the body by scanning them with x-rays and using a computer to construct a series of cross-sectional scans along a single axis. Panitumumab-IRDye800 is an imaging agent composed of panitumumab, a monoclonal antibody, linked to a fluorescent dye called IRDye800. Upon administration, panitumumab-IRDye800 targets and binds to receptors on tumor cells. This allows the tumor cells to be detected using fluorescence imaging during surgery. Adding 111In-panitumumab SPECT/CT imaging to intraoperative panitumumab-IRDye800 fluorescence imaging may be more effective at detecting disease in patients with head and neck cancer.
Phase I
I
Rosenthal, Eben
NCT05945875
VICC-EDHAN23204P
111In-Panitumumab for Nodal Staging in Patients with Head and Neck Cancer
Multiple Cancer Types
This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography/computed tomography (SPECT/CT). SPECT/CT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.
Head/Neck,
Phase I
I
Rosenthal, Eben
NCT05901545
VICC-EDHAN23201P
An Imaging Agent (89Zr Panitumumab) with PET/CT for Diagnosing Primary Lesions and/or Metastases in Patients with Head and Neck Squamous Cell Carcinoma
Head/Neck
Head/Neck
This phase I trial evaluates the usefulness of an imaging agent (zirconium Zr 89 panitumumab [89Zr panitumumab]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing primary tumors and/or the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. 89Zr panitumumab is an investigational imaging agent that contains a small amount of radiation, which makes it visible on PET scans. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr panitumumab, to allow imaging of the function of different cells and organs in the body. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential disease tissue where it occurs in patients body. The combined PET/CT scanner is a special type of scanner that allows imaging of both structure (CT) and function (PET) following the injection of 89Zr panitumumab. This 89Zr panitumumab PET/CT may be useful in diagnosis of primary tumors and/or metastasis in patients with head and neck squamous cell carcinoma.
Head/Neck
I
Topf, Michael
NCT05747625
VICCHN2279
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of
safety and effectiveness of Medtronic market-released products. The Registry data is intended
to benefit and support interests of patients, hospitals, clinicians, regulatory bodies,
payers, and industry by streamlining the clinical surveillance process and facilitating
leading edge performance assessment via the least burdensome approach.
safety and effectiveness of Medtronic market-released products. The Registry data is intended
to benefit and support interests of patients, hospitals, clinicians, regulatory bodies,
payers, and industry by streamlining the clinical surveillance process and facilitating
leading edge performance assessment via the least burdensome approach.
Not Available
Shen, Sharon
NCT01524276
CRE-ARR0001
Virtual Patient-Specific 3D Specimen Maps for Adjuvant Head & Neck Radiotherapy Planning
Head/Neck
Head/Neck
This study measures the impact of patient-specific 3D specimen maps on adjuvant radiation treatment volumes and doses to critical organs.
Head/Neck
N/A
Topf, Michael
NCT05743569
VICCHN22102
Avelumab or Hydroxychloroquine with or without Palbociclib for the Treatment of Stage II-III Breast Cancer, PALAVY Study
Breast
Breast
This phase II trial investigates the effect of avelumab or hydroxychloroquine sulfate with or without palbociclib in treating patients with stage II-III breast cancer that is positive for disseminated tumor cells (DTCs) after curative therapy. DTCs are breast cancer cells that are asleep (dormant) in the bone marrow. There are multiple ways in which these cells stay alive, and three of these mechanisms are inhibited by the drugs in this trial. First, dormant cancer cells need a protein signal pathway involving CDK 4/6 to start dividing once they wake up in order to survive as an active cancer cell. Palbociclib works by blocking the CDK 4/6 protein and by doing so may limit the dormant cancer cell from being able to survive. In addition, palbociclib may also help both of the other drugs in the trial to work better. Second, dormant cancer cells also use a process called autophagy to generate their own nutrition, which can allow them to stay asleep. Hydroxychloroquine has been shown to block autophagy, which leads to starvation of the cells. Third, dormant cancer cells are able to hide from the bodys immune system. The immune system sends a type of cell called T cells throughout the body to detect and fight infections and diseasesincluding cancers. One way the immune system controls the activity of T cells is through the PD-1/PD-L1 (programmed cell death protein-1) pathway. However, some cancer cells hide from T-cell attack by taking control of the PD-1/PD-L1 interaction and this stops T cells from attacking cancer cells. Avelumab is an antibody designed to block the PD-1/PD-L1 pathway and helps the immune system in detecting and fighting dormant cancer cells. Because palbociclib, hydroxychloroquine, and avelumab work on the mechanisms that keep the dormant cells alive, taking one or a combination of these drugs may be able to eliminate DTCs.
Breast
II
Reid, Sonya
NCT04841148
VICCBRE2161
Acalabrutinib for the Treatment of Chronic Graft Versus Host Disease
Miscellaneous
Miscellaneous
This phase II trial studies how well acalabrutinib works in treating patients with chronic graft versus host disease. Acalabrutinib may be an effective treatment for graft-versus-host disease caused by a stem cell transplant.
Miscellaneous
II
Kitko, Carrie
NCT04198922
VICCCTT2122
Sparing Bone Marrow in Patients with Stage IIB-IV Lung Cancer, VMAT Trial
Lung
Lung
This phase II trial tests whether designing radiation to avoid bone marrow in the spine (vertebral bone marrow) leads to less reduction of white blood cell counts (lymphopenia) in patients with lung cancer. This sparing technique could lead to better disease control and outcome.
Lung
N/A
Osmundson, Evan
NCT05248256
VICCRAD2189
