MyelomaPhase 1/2NCT02907073

Positron Emission Tomography (PET) Imaging Studies With NIS Reporter

A Phase 1/2 study testing BF4 in people with Myeloma and Endometrial Cancer, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The goal of this proposal is to perform first-in-man evaluation of and experimental imaging agent F-18 tetrafluoroborate (BF4) or (TFB). Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Myeloma, Endometrial Cancer
What is being tested?: BF4
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Sep 2016to Dec 2017
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Four male and four female healthy volunteers, greater than 21 years of age.
Subjects must provide written informed consent.
Willingness to provide all biological specimens as required by the protocol

Who cannot join

Volunteers with any of the following are ineligible to enroll in this study:
Have currently clinically significant cancer, neurologic, hepatic, renal, pulmonary, metabolic, or endocrine disturbances, especially thyroid disease;
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;
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 Human Chorionic Gonadotropin (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]BF4 unless the screening urine pregnancy test falls within 48 hours of injection.
Volunteers who, in the opinion of the investigator, are otherwise unsuitable for a study of this type;
History of severe drug allergy or hypersensitivity; or
Volunteers who had received an investigational medication within the last 30 days or who have participated in a clinical trial with any experimental medication or radiopharmaceutical 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.
Volunteers 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.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: First In-human PET Imaging Studies With NIS Reporter [18F]BF4

The goal of this proposal is to perform first-in-man evaluation of and experimental imaging agent F-18 tetrafluoroborate (BF4) or (TFB).

Read the detailed description

F-18 tetrafluoroborate (BF4) or (TFB) is being used as a PET (Positron Emission Tomography) 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 I-123 or Tc-99m SPECT for monitoring hNIS transduction effected by viral therapies. The proposed work is designed to 1) evaluate its safety, biodistribution, metabolism and radiation dosimetry characteristics in 8 healthy human volunteers and 2) evaluate the imaging feasibility in comparison with I-123 or 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.

Conditions: Myeloma, Endometrial Cancer
Being tested: BF4
Medical subject headings: Neoplasms, Plasma Cell, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BF4Drug
Also called Tetrafluoroborate, TFB
Single IV dose of 9-11 millicurie (mCi) sodium [Fluorine-18] radiolabeled B4^F

Study groups in NCT02907073
Study group	Role	What they receive
Healthy Volunteers	Experimental	At the study visit, healthy subjects will have an initial physical exam, urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration and blood sampling. Vital signs, and blood samples will be obtained. Subjects will receive an infusion [18F]BF4 over 1 minute and PET imaging will begin. Three (3) PET/CT scanning procedures will be performed over a period of approximately 4 hours with two rest breaks in between. Venous blood samples for clinical laboratory tests will be taken before radiotracer administration and at 1.5 hours post-administration of radiotracer. In addition, venous blood samples will be taken during the PET/CT scans to determine blood pharmacokinetics and metabolite evaluation. Physical exam will be repeated at the end of the study. Receives: Drug: BF4
Myeloma patients	Experimental	For cancer patients undergoing virus treatments, subjects will undergo [18F]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of [18F]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of [18F]BF4 in up to three myeloma patients when the site is accessible for biopsy. Receives: Drug: BF4
Endometrial cancer patients	Experimental	For cancer patients undergoing virus treatments, subjects will undergo [18F]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of [18F]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of [18F]BF4 in up to three endometrial cancer patients when the site is accessible for biopsy. Receives: Drug: BF4

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
F-18 BF4 concentrations in major tissues (e.g., heart, blood pool, lung, liver, thyroid, stomach, kidney, brain, muscle) will be evaluated from the PET images from 0-240 minutes post-administration. Results will be used to compute radiation dosimetry estimates.
Measured: 0-240 minutes

Secondary outcomes (1)

Amount of Imaging Agent in Tumor (Uptake) in Myeloma and Endometrial Cancer Patients
Areas of positive uptake within tumor, relative to background, measured by Standardized Update Value (SUV). PET SUV is tissue concentration/injected dose/body weight in grams.
Measured: Baseline, Day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016Dec 2017

First posted20 Sep 2016 (estimated)
Study startSep 2016
Primary completionDec 2017
Study completionDec 2017

Why it stopped: pursuing IND

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MyelomaStudies 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 1/2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02907073
Sponsor's protocol ID: 15-002494
Status last verified: May 2019
First submitted: 13 Sep 2016
Last updated: 17 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Active, not recruitingPhase 2
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All Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: First In-human PET Imaging Studies With NIS Reporter [18F]BF4
ClinicalTrials.gov ID: NCT02907073
Acronym / sponsor ID: 15-002494
Conditions: Myeloma, Endometrial Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: pursuing IND
Enrolment: 8 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: Sep 2016
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 20 Sep 2016 (estimated)
Results: Posted 17 May 2019

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 and experimental imaging agent F-18 tetrafluoroborate (BF4) or (TFB).

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Healthy Volunteers	Experimental	Drug: BF4At the study visit, healthy subjects will have an initial physical exam, urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration and blood sampling. Vital signs, and blood samples will be obtained. Subjects will receive an infusion [18F]BF4 over 1 minute and PET imaging will begin. Three (3) PET/CT scanning procedures will be performed over a period of approximately 4 hours with two rest breaks in between. Venous blood samples for clinical laboratory tests will be taken before radiotracer administration and at 1.5 hours post-administration of radiotracer. In addition, venous blood samples will be taken during the PET/CT scans to determine blood pharmacokinetics and metabolite evaluation. Physical exam will be repeated at the end of the study.
Myeloma patients	Experimental	Drug: BF4For cancer patients undergoing virus treatments, subjects will undergo [18F]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of [18F]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of [18F]BF4 in up to three myeloma patients when the site is accessible for biopsy.
Endometrial cancer patients	Experimental	Drug: BF4For cancer patients undergoing virus treatments, subjects will undergo [18F]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of [18F]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of [18F]BF4 in up to three endometrial cancer patients when the site is accessible for biopsy.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Four male and four female healthy volunteers, greater than 21 years of age.
Subjects must provide written informed consent.
Willingness to provide all biological specimens as required by the protocol

Key exclusion criteria (18 listed)

Have currently clinically significant cancer, neurologic, hepatic, renal, pulmonary, metabolic, or endocrine disturbances, especially thyroid disease;
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 Human Chorionic Gonadotropin (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]BF4 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
BF4Also: Tetrafluoroborate, TFBSingle IV dose of 9-11 millicurie (mCi) sodium [Fluorine-18] radiolabeled B4^F	Drug	Endometrial cancer patients, Healthy Volunteers, Myeloma patients

Primary outcome

Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Time frame: 0-240 minutes
F-18 BF4 concentrations in major tissues (e.g., heart, blood pool, lung, liver, thyroid, stomach, kidney, brain, muscle) will be evaluated from the PET images from 0-240 minutes post-administration. Results will be used to compute radiation dosimetry estimates.

1 secondary outcome

Amount of Imaging Agent in Tumor (Uptake) in Myeloma and Endometrial Cancer Patients
Time frame: Baseline, Day 9

Results and safety

Results posted to the registry on 17 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Volunteers	8	8
Myeloma Patients	0	0
Endometrial Cancer Patients	0	0

Primary outcome: Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers

Time frame: 0-240 minutes. Mean (Standard Deviation). Unit: standardized uptake value (SUV)

Measure	Healthy Volunteers n = 8	Myeloma Patients n = 0	Endometrial Cancer Patients n = 0
Bone uptake - 2 h males	0.8 (0.39)	–	–
Bone uptake - 2 h females	1.4 (0.5)	–	–
Brain uptake - 2 h males	0.39 (0.14)	–	–
Brain uptake - 2 h females	0.42 (0.15)	–	–
Breast uptake - 2 h females	2.8 (0.4)	–	–
Gallbladder uptake - 2 h males	2.7 (1.5)	–	–
Gallbladder uptake - 2h females	3.7 (1.0)	–	–
Intestinal uptake - 2h males	2.9 (1.0)	–	–

Population analysed: Outcome measures were performed in study arm of eight healthy volunteers. F or the myeloma and endometrial cancer arms of the study, the study was terminated due to pursuing Investigational New Drug application (IND).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data collection was defined as 24 hours following last administration of study treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Volunteers	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Myeloma Patients	0 of 0	0 of 0	0
Endometrial Cancer Patients	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): The study was terminated due to pursuing Investigational New Drug application (IND).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

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A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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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 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 1/2 study testing BF4 in people with Myeloma and Endometrial Cancer, 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 3 inclusion and 18 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: stopped early, as of the sponsor's last update on 17 May 2019. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers (time frame: 0-240 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02907073.

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 17 May 2019.