Clinical Trials Using 18F-Fluoromisonidazole

This phase III trial compares personalized chemoradiation therapy to standard chemoradiation therapy for the treatment of human papilloma virus (HPV)-positive throat cancer. The combination of radiation therapy and chemotherapy (chemoradiation) is a standard treatment approach for people with HPV-positive throat cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors, while chemotherapy drugs, such as cisplatin, carboplatin and fluorouracil (5-FU), stop the growth of tumor cells, either by killing the cells or stopping them from dividing. However, this standard combination may cause severe short- and long-term side effects, such as sores in the mouth and gut that can make it difficult to swallow, sore throat, and changes in taste. Hypoxic tumors are known to be resistant to radiation therapy and chemotherapy and are more likely to come back after treatment. Using an imaging agent, like 18F-Fluoromisonidazole (18F-FMISO), during a positron emission tomography (PET)/computed tomography (CT) scan can help identify hypoxic tumors. The results of the 18F-FMISO PET/CT can be used to help personalize the amount of chemoradiation the patient will receive, either a smaller or larger amount, for the remainder of treatment. Personalized chemoradiation therapy may be better than standard chemoradiation therapy for the treatment of HPV-positive throat cancer.

This phase II trial tests whether smaller doses (de-escalation) radiation therapy with cisplatin or carboplatin and fluorouracil chemotherapy works to shrink tumors in patients with p16 negative oropharyngeal and head and neck squamous cell cancers of unknown primary and negative or positive p16 laryngeal and hypopharyngeal cancers. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Fluorouracil is in a class of medications called antimetabolite agents. It works by stopping the growth and spread of tumor cells. Giving chemotherapy with radiation therapy may kill more tumor cells and support subsequent neck dissection. De-escalated radiation therapy and chemotherapy may be an effective treatment method and improve the quality of life in patients with head and neck cancers.

This phase II trial evaluates whether lower-dose radiation therapy in combination with standard of care chemotherapy works to treat and reduce side effects in patients with human papillomavirus positive, stage I-IVa oropharyngeal cancer. Radiation therapy such as intensity-modulated radiation therapy, volume modulated arc therapy, and proton beam radiation therapy use high energy rays or protons to kill tumor cells and shrink tumors. Chemotherapy drugs such as cisplatin, carboplatin, and fluorouracil work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

This phase I trial is to find out the side effects of personalized radiation therapy based on levels of tumor hypoxia (tumor cells have low oxygen) identified on FMISO-PET/CT and MRI in treating patients with esophageal cancer. PET portion of the scan uses radioactive imaging agents, called “tracers,” to look at the tumor so that physicians will have more information specific to the tumor. [18F]FMISO is a tracer used to look at how much oxygen is in the tumor. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Diagnostic procedures such as [18F]FMISO PET/CT may help researchers better identify the dose of radiation treatment needed for individual tumors.

This phase II trial studies how well 18F- fluoromisonidazole (FMISO) works with positron emission tomography (PET)/magnetic resonance imaging (MRI) in assessing participants with malignant (cancerous) brain tumors. FMISO provides information about the oxygen levels in a tumor, which may affect how the tumor behaves. PET/MRI imaging produces images of the brain and how the body functions. FMISO PET/MRI may help investigators see how much oxygen is getting in the brain tumors.

This phase I trial studies the usefulness of [18F]FMISO-PET/MRI in monitoring treatment response in patients with HER2+ stage II-III breast cancer who are receiving therapy before surgery. It is thought that many cancers contain areas with low oxygen. This lack of oxygen may affect the growth of cancer cells and the response to different cancer treatments. 18F]FMISO is a small molecule with a radioactive portion call fluorine-18 (18F). [18F]FMISO builds up in cells that do not have enough oxygen. PET is a type of imaging test that uses a small amount of radioactive drug injected into the vein to see how cells or tissues are functioning. It is combined with an MRI machine which uses magnetic fields and radio waves to generate images of the inside of the body. Diagnostic procedures, such as [18F]FMISO-PET/MRI, may help monitor and predict treatment response in patients with breast cancer.

This early phase I trial studies the safety and feasibility of two investigational imaging drugs ([18F]FET and [18F]FMISO) used with positron emission tomography/magnetic resonance imaging (PET/MRI) scans in detecting residual high grade glioma patients undergoing radiation therapy. [18F]FET is an amino acid with a radioactive portion called fluorine-18 (18F). This drug enters normal and tumor cells through system L amino acid transport which recognizes amino acids normally present in the blood. This radioactive investigational drug allows doctors to take pictures of the brain using PET and to measure levels of amino acid transport. Many studies have shown [18F]FET is effective for imaging high grade glioma, but its usefulness soon after completing of radiation therapy is not known. [18F]FMISO is a small molecule that gets trapped in tumor tissue with very low oxygen levels (hypoxia) with a radioactive portion called (18F). [18F]FMISO enters normal and tumors cells but is trapped in cells with hypoxia. This radioactive investigational drug allows doctors to take pictures of the brain using PET and to detect tumor tissue with hypoxia. Several studies have shown [18F]FMISO is effective for detecting hypoxia in high grade glioma, but its usefulness for detecting glioma after therapy is not known. PET is a type of imaging test that uses a small amount of radioactive drug injected into a vein to see how cells or tissues are functioning. PET can also be combined with magnetic resonance imaging (MRI) which uses magnetic fields and radio waves to generate images of the inside of the body. [18F]FET and [18F]FMISO PET/MRIs may help scientists detect active glioma sooner after therapy and to tell the difference between treatment effects and active brain tumors.

This clinical trial is studying how well magnetic resonance imaging (MRI) in combination with 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans works in assessing a decrease in the amount of oxygen (hypoxia) in tumor cells and in guiding adaptive radiation treatment in patients with head and neck cancer or cancer that has spread to the brain from where it first started (brain metastasis). Both head and neck cancer and brain metastases can be treated with radiation. Previous research studies have shown that the amount of oxygen that goes towards cancer cells prior to their radiation treatments predicts how the cancer cells will respond to radiation treatment. MRI is a type of imaging technique that uses radio waves and large magnets to produce detailed images of areas inside the body. 18F-FMISO is a radioactive substance that binds to hypoxic tumor cells and emits radiation, allowing the tumor cells to be visualized using PET/CT, which is an imaging technique that combines PET and CT in a single machine. It is used to make detailed, computerized images of inside the body. By combining MRI with 18F-FMISO PET/CT, researchers may be able to develop an MRI sequence that can be used to evaluate hypoxia in tumor cells and predict response to treatment in patients with head and neck cancer or brain metastases.