Myeloma Before MV-NIS TreatmentPhase 1NCT03456908
F-18 TFB-PET Studies in Cancer Patients Undergoing NIS-containing Viral Therapies
A Phase 1 study testing 18F-TFB-PET in people with Myeloma Before MV-NIS Treatment and Endometrial Cancer Before VSV-hINF-NIS Treatment, run by Mayo Clinic at 1 site in United States.
Trial summary
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. . Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Myeloma Before MV-NIS Treatment, Endometrial Cancer Before VSV-hINF-NIS Treatment
- What is being tested?
- 18F-TFB-PET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to 31 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Myeloma Patients
- Patients who are currently participating in Mayo Clinic MV-NIS trial (IRB: 06-005263) and agree to enroll in additional 18F-TFB PET studies.
- Subjects are greater than 21 years of age.
- Subjects must provide written informed consent.
- 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.
Who cannot join
- Myeloma Patients
- Patients with any of the following are ineligible to enroll in this study:
- Current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following:
- Cardiac surgery or myocardial infarction within the last 6 months.
- Unstable angina.
- Coronary artery disease that required a change in medication within the last 3 months.
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- Decompensated congestive heart failure.
- 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.
- Severe mitral or aortic valvular disease.
- Uncontrolled high blood pressure.
- Congenital heart disease. Before enrolling a patient with any of the above conditions, the co- investigator must contact the principal investigator.
- History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
- Clinically significant infectious disease, including AIDS or HIV infection or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2.
- Women of childbearing potential must not be pregnant (negative urine β-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.
- Patients who, in the opinion of the investigator, are otherwise unsuitable for a study of this type.
- History of severe drug allergy or hypersensitivity.
- 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.
- 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.
- 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:
- Current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following:
- Cardiac surgery or myocardial infarction within the last 6 months.
- Unstable angina.
- Coronary artery disease that required a change in medication within the last 3 months.
- Decompensated congestive heart failure.
- 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.
- Severe mitral or aortic valvular disease.
- Uncontrolled high blood pressure.
- Congenital heart disease. Before enrolling a patient with any of the above conditions, the co- investigator must contact the principal investigator.
- History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
- Clinically significant infectious disease, including AIDS or HIV infection or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2.
- Women of childbearing potential must not be pregnant (negative urine β-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.
- Patients who, in the opinion of the investigator, are otherwise unsuitable for a study of this type.
- History of severe drug allergy or hypersensitivity.
- 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.
- 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.
- Patients who are taking drugs with narrow therapeutic windows, such as theophylline, or warfarin, heparin and other anticoagulant therapies.
Trial locations and contacts
1 site in 1 country.
About this study
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. .
Read the detailed description
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. Imaging of functional hNIS activity in tissues with [18F]BF4 is anticipated to provide superior sensitivity and image quality to Tc-99m SPECT for monitoring hNIS transduction effected by viral therapies. The proposed work is designed to 1) evaluate the imaging feasibility in comparison with Tc-99m SPECT of hNIS expression in a) 10 myeloma patients treated with Edmonston Measles virus-NIS (MV-NIS) and b) 10 endometrial cancer patients treated with vesicular stomatitis virus engineered to express human interferon-and NIS (VSV-hINF-NIS). This data will be necessary to support future regulatory submissions.
- Being tested
- 18F-TFB-PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-TFB-PETCombination product
Infusion of F-18 TFB and PET / CT imaging
| Study group | Role | What they receive |
|---|---|---|
| myeloma before MV-NIS treatment | Experimental | Perform [18F]BF4-PET and [99mTc]pertechnetate-SPECT imaging in 10 patients with myeloma before MV-NIS treatment, and at Day 8-9 to monitor NIS activity in the tumors. To show the correlation of positive regional uptake with tissue histopathology for NIS, biopsies will be taken, when accessible, after the day 8 scan. Patients will be selected from subjects electing to participate in IRB 06-005263 at Mayo Clinic: "Phase I/II Trial of Systemic Administration of Edmonston Strain of Measles Virus, Genetically Engineered to Express NIS, with or without Cyclophosphamide, in Patients with Recurrent or Refractory Multiple Myeloma", Receives: Combination Product: 18F-TFB-PET |
| endometrial cancer before VSV-hINF-NIS treatment | Experimental | Perform [18F]BF4-PET and [99mTc]pertechnetate-SPECT imaging in 10 patients with endometrial cancer before VSV-hINF-NIS treatment, and at Day 3-5 to monitor NIS activity in the tumors. To show the correlation of positive regional uptake with tissue histopathology for NIS, biopsies will be taken, when accessible, after the day 3-5 scan. Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients with Metastatic and/or Incurable Endometrial and Epithelial Ovarian Cancer", IRB 15-007000 Receives: Combination Product: 18F-TFB-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the uptake and distribution of the imaging agent 18F-TFB
This is a preliminary study and all analyses will be exploratory in nature.
Measured: up to 10 days
Secondary outcomes (1)
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
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start16 Mar 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloma Before MV-NIS TreatmentStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim DeGrado, Mayo Clinic
- Investigators
- Timothy R DeGrado, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456908
- Sponsor's protocol ID
- F18 17-008847
- Status last verified
- Sep 2020
- First submitted
- 6 Feb 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: N/A no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F-18 TFB-PET Studies in Cancer Patients Undergoing NIS-containing Viral Therapies
- ClinicalTrials.gov ID
- NCT03456908
- Acronym / sponsor ID
- F18 17-008847
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Detailed description
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. Imaging of functional hNIS activity in tissues with [18F]BF4 is anticipated to provide superior sensitivity and image quality to Tc-99m SPECT for monitoring hNIS transduction effected by viral therapies. The proposed work is designed to 1) evaluate the imaging feasibility in comparison with Tc-99m SPECT of hNIS expression in a) 10 myeloma patients treated with Edmonston Measles virus-NIS (MV-NIS) and b) 10 endometrial cancer patients treated with vesicular stomatitis virus engineered to express human interferon-and NIS (VSV-hINF-NIS). This data will be necessary to support future regulatory submissions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myeloma before MV-NIS treatment | Experimental | Combination Product: 18F-TFB-PETPerform [18F]BF4-PET and [99mTc]pertechnetate-SPECT imaging in 10 patients with myeloma before MV-NIS treatment, and at Day 8-9 to monitor NIS activity in the tumors. To show the correlation of positive regional uptake with tissue histopathology for NIS, biopsies will be taken, when accessible, after the day 8 scan. Patients will be selected from subjects electing to participate in IRB 06-005263 at Mayo Clinic: "Phase I/II Trial of Systemic Administration of Edmonston Strain of Measles Virus, Genetically Engineered to Express NIS, with or without Cyclophosphamide, in Patients with Recurrent or Refractory Multiple Myeloma", |
| endometrial cancer before VSV-hINF-NIS treatment | Experimental | Combination Product: 18F-TFB-PETPerform [18F]BF4-PET and [99mTc]pertechnetate-SPECT imaging in 10 patients with endometrial cancer before VSV-hINF-NIS treatment, and at Day 3-5 to monitor NIS activity in the tumors. To show the correlation of positive regional uptake with tissue histopathology for NIS, biopsies will be taken, when accessible, after the day 3-5 scan. Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients with Metastatic and/or Incurable Endometrial and Epithelial Ovarian Cancer", IRB 15-007000 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Myeloma Patients
- Patients who are currently participating in Mayo Clinic MV-NIS trial (IRB: 06-005263) and agree to enroll in additional 18F-TFB PET studies.
- Subjects are greater than 21 years of age.
- Subjects must provide written informed consent.
- Agree to provide biopsy of tumor indicated on PET for research purposes, if accessible.
Key exclusion criteria (38 listed)
- Myeloma Patients
- Current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following:
- History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
- Clinically significant infectious disease, including AIDS or HIV infection or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2.
- Women of childbearing potential must not be pregnant (negative urine β-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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-TFB-PETInfusion of F-18 TFB and PET / CT imaging | Combination product | endometrial cancer before VSV-hINF-NIS treatment, myeloma before MV-NIS treatment |
Primary outcome
Evaluate the uptake and distribution of the imaging agent 18F-TFB
Time frame: up to 10 days
This is a preliminary study and all analyses will be exploratory in nature.
1 secondary outcome
Imaging Sensitivities
Time frame: up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. N/A no plan to share IPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy R DeGrado, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-TFB-PET in people with Myeloma Before MV-NIS Treatment and Endometrial Cancer Before VSV-hINF-NIS Treatment, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the uptake and distribution of the imaging agent 18F-TFB (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.