Endometrial Cancer Before VSV-hINF-NIS Treatment Clinical Trial
Official title:
F-18 TFB-PET Studies in Cancer Patients Undergoing NIS-containing Viral Therapies
| Verified date | September 2020 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The goal of this proposal is to perform first-in-man evaluation of the imaging probe F-18 tetrafluoroborate (BF4) as a PET imaging biomarker for expression of the human sodium/iodide symporter (hNIS) in tissues. .
| Status | Completed |
| Enrollment | 2 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | December 31, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility |
Inclusion Criteria: Myeloma Patients 1. Patients who are currently participating in Mayo Clinic MV-NIS trial (IRB: 06-005263) and agree to enroll in additional 18F-TFB PET studies. 2. Subjects are greater than 21 years of age. 3. Subjects must provide written informed consent. 4. Agree to provide biopsy of tumor indicated on PET for research purposes, if accessible. Endometrial Cancer Patients 1 Patients who are currently participating in Mayo Clinic VSV-hINF-NIS trial (IRB 15-007000) and agree to enroll in additional 18F -TFB-PET studies. 2. Subjects are greater than 21 years of age. 3. Subjects must provide written informed consent. 4. Agree to provide biopsy of tumor indicated on PET for research purposes, if accessible. Exclusion Criteria: Myeloma Patients Patients with any of the following are ineligible to enroll in this study: 1. Current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following: 1. Cardiac surgery or myocardial infarction within the last 6 months. 2. Unstable angina. 3. Coronary artery disease that required a change in medication within the last 3 months. 4. Decompensated congestive heart failure. 5. Significant cardiac arrhythmia or conduction disturbance, particularly those resulting in atrial or ventricular fibrillation, or causing syncope, near syncope, or other alterations in mental status. 6. Severe mitral or aortic valvular disease. 7. Uncontrolled high blood pressure. 8. Congenital heart disease. Before enrolling a patient with any of the above conditions, the co- investigator must contact the principal investigator. 2. History of drug or alcohol abuse within the last year, or prior prolonged history of abuse. 3. Clinically significant infectious disease, including AIDS or HIV infection or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2. 4. Women of childbearing potential must not be pregnant (negative urine ß-HCG at the time of screen) or lactating over the course of the study. A commercial urine dipstick test will be performed within 48 hours prior to injection of 18F-TFB PET unless the screening urine pregnancy test falls within 48 hours of injection. 5. Patients who, in the opinion of the investigator, are otherwise unsuitable for a study of this type. 6. History of severe drug allergy or hypersensitivity. 7. Patients who had received an investigational medication within the last 30 days or who have participated in a clinical trial involving medications other than the related MV-NIS or VSV-NIS viruses in the last 30 days. Additionally, the time between the last dose of the previous experimental medication and enrollment (completion of screening assessments) must be at least equal to 5 times the terminal half-life of the previous experimental medication. 8. Patients with current clinically significant medical comorbidities that might pose a potential safety risk, interfere with the absorption or metabolism of the study medication, or limit interpretation of the study results. These include but are not limited to clinically significant hepatic, renal, pulmonary, metabolic or endocrine disease, cancer, HIV infection and AIDS. 9. Patients who are taking drugs with narrow therapeutic windows, such as theophylline, or warfarin, heparin and other anticoagulant therapies. Endometrial Cancer Patients Patients with any of the following are ineligible to enroll in this study: 1. Current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following: 1. Cardiac surgery or myocardial infarction within the last 6 months. 2. Unstable angina. 3. Coronary artery disease that required a change in medication within the last 3 months. 4. Decompensated congestive heart failure. 5. Significant cardiac arrhythmia or conduction disturbance, particularly those resulting in atrial or ventricular fibrillation, or causing syncope, near syncope, or other alterations in mental status. 6. Severe mitral or aortic valvular disease. 7. Uncontrolled high blood pressure. 8. Congenital heart disease. Before enrolling a patient with any of the above conditions, the co- investigator must contact the principal investigator. 2. History of drug or alcohol abuse within the last year, or prior prolonged history of abuse. 3. Clinically significant infectious disease, including AIDS or HIV infection or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2. 4. Women of childbearing potential must not be pregnant (negative urine ß-HCG at the time of screen) or lactating over the course of the study. A commercial urine dipstick test will be performed within 48 hours prior to injection of 18F-TFB PET unless the screening urine pregnancy test falls within 48 hours of injection. 5. Patients who, in the opinion of the investigator, are otherwise unsuitable for a study of this type. 6. History of severe drug allergy or hypersensitivity. 7. Patients who had received an investigational medication within the last 30 days or who have participated in a clinical trial with any experimental medication in the last 30 days. Additionally, the time between the last dose of the previous experimental medication and enrollment (completion of screening assessments) must be at least equal to 5 times the terminal half-life of the previous experimental medication. 8. Patients with current clinically significant medical comorbidities, that might pose a potential safety risk, interfere with the absorption or metabolism of the study medication or limit interpretation of the study results. These include but are not limited to clinically significant hepatic, renal, pulmonary, metabolic or endocrine disease, cancer, HIV infection and AIDS. 9. Patients who are taking drugs with narrow therapeutic windows, such as theophylline, or warfarin, heparin and other anticoagulant therapies. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate the uptake and distribution of the imaging agent 18F-TFB | This is a preliminary study and all analyses will be exploratory in nature. | up to 10 days | |
| Secondary | Imaging Sensitivities | Comparisons will be made between 18F -TFB-PET/CT scans and 99mTc-SPECT/CT scans for feasibility to monitor expression of NIS in tumors following oncoviral treatments in the subjects | up to 10 days |