Neuro-Degenerative DiseaseEarly Phase 1[11C]ButanolNCT04050800
Carbon-11 Butanol: Whole Body Radiochemical and Radiation Safety
A Early Phase 1 study testing Carbon 11 Butanol in people with Neuro-Degenerative Disease, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This will be a Phase 1, open label, imaging study of radiochemical and radiation safety in healthy volunteers. Using positron emission tomography (PET) and in-line computed tomography (CT), the whole body (WB) biokinetics of Carbon-11 butanol will be quantified with serial scans acquired every 3 minutes for two hours. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuro-Degenerative Disease
- What is being tested?
- Carbon 11 Butanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2020to 5 Jan 2021
- Phase
- Early 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to give informed consent.
- age 18-89
- Subjectively healthy and, in the opinion of the investigators, likely to tolerate the imaging procedures and be compliant with the schedule of follow up telephone calls.
- Normal hemodynamic function. Systolic blood pressure and pulse must be higher than 120 mmHg and 60 beats per minute while sitting. At the discretion of the investigators, people who regularly engage in vigorous exercise more than four times per week may be enrolled if their systolic blood pressure and pulse are higher than 100 mmHg and 50 beats per minute while sitting.
- Unremarkable electrocardiograms, with PR intervals of less than 200 mSec and QTcF intervals (corrected with Frederica's method) of less than 440 mSec.
- No concurrent medications with the exception of p.r.n. NSAIDS, which must be discontinued one week prior to PET scanning.
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- Willing and able to refrain from abusing any recreational drugs, including marijuana, and drink less than one unit of alcoholic beverages per day starting one week prior to PET scanning, and avoided for the next four weeks.
- Willing to refrain from donating blood for four (4) weeks before the study and for four (4) weeks after the study.
- Willing to refrain from participating in any other research study that requires taking medication for four (4) weeks before the study and for four (4) weeks after the study.
- Willing to refrain from being vaccinated for four (4) weeks before the study and for four (4) weeks after the study.
- All clinical laboratory test results within normal limits or not clinically significant. For example, elevated bilirubin levels in subjects with Gilbert's syndrome will be allowed, as will small red blood cell volumes in healthy people with sickle cell trait.
Who cannot join
- Subjects may not be a member of a vulnerable population.
- Women may not be pregnant or breast feeding.
- History of multiple hypersensitivity reactions (atopia), as indicated by allergies to multiple medications, foods, and seasonal pollens.
- History, physical examination, or clinical laboratory tests suggestive of a condition, disorder, or disease that could adversely affect drug absorption, distribution, metabolism, or elimination (ADME) of the tracer, including chronic liver or renal failure.
- Positive urine toxicology screen for recreational drugs other than marijuana.
- May not have taken any controlled medications, including other study drugs, in the 30 days prior to PET scanning or for 10 half-lives, whichever is longer.
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- May not have donated blood in the 30 days prior to PET scanning.
- May not have participated in research administering drugs in the last 30 days.
- May not have been vaccinated in the 30 days prior to PET scanning.
- May not have been exposed to radiation during research of more than 10 mSv during the last year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterizing the Safety of [Carbon-11]Butanol and Estimating the Test-Retest Variance in Measurements of Its Whole Body Biokinetics Under Zero-Biological-Change Conditions
This will be a Phase 1, open label, imaging study of radiochemical and radiation safety in healthy volunteers. Using positron emission tomography (PET) and in-line computed tomography (CT), the whole body (WB) biokinetics of Carbon-11 butanol will be quantified with serial scans acquired every 3 minutes for two hours. Vital signs (VS), electrocardiograms (ECGs) and clinical laboratory tests of intrernal organ function will be acquired before and at several timepoints after administration of the radiopharmaceutical. Radiation exposures will be estimated with the MIRD Formalism.
Read the detailed description
Vital signs (VSs) will be measured, electrocardiograms (ECGs) will be acquired, and blood will be sent to the clinical laboratory for safety assessments before a single dose, intravenous (IV) administration of 555 MBq of Carbon-11 butanol. VSs will be re-measured, ECGs will be acquired again, and more blood will be sent to the clinical laboratory for repeat safety assessments after 2 hours of whole body (WB) scanning. WB scanning will consist of imaging acquisition sweeps of 200 cm from head-to-toe over 180 secs (3 min). Up to 40 sweeps per imaging session will be performed. The subjects will then be given a rest period ("coffee break") for about two hours, after which the entire sequence of events will be repeated. The primary outcome measure will be related to radiation safety derived from the areas under the time-activity curves (AUCs) for internal organs. Co-primary clinical safety measures will include changes in VSs, ECG parameters such as the PR and corrected QT intervals, and clinical laboratory tests, such as proteins that reflect renal and hepatic function. Secondary endpoints will include the time-activity curves (TACs) and total volumes of distribution (VT) in several brain regions. The results should allow calculation of the repeatability coefficients (RCs) under zero-biological-change conditions. RC values will be essential for understanding whether future measurements of effect sizes in response to therapeutic maneuvers or the differences between groups are meaningful.
- Conditions
- Neuro-Degenerative Disease
- Being tested
- Carbon 11 Butanol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon 11 ButanolDrug
Also called [11C]Butan-1-Ol
Two sequential administrations of a PET tracer
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | Subjects will be administered two sequential doses of the radiopharmaceutical under nearly zero-biological-change conditions. Receives: Drug: Carbon 11 Butanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Dose (ED)
Fundamental radiation dose quantity in the International Commission on Radiological Protection (ICRP) system of radiological protection. Calculated with OLINDA-EXM software (OLINDA/EXM stands for Organ Level INternal Dose Assessment/EXponential Modeling).
Measured: Day 1, from the measurements of exposures during the first 2 hours post administration.
Secondary outcomes (5)
Change in Radiochemical Safety Assessments
Change in pulse
Measured: Pulse at two hours post administration compared to pulse shortly before administration.
Change in Radiochemical Safety Assessments
Change in blood pressure
Measured: Blood pressure at two hours post administration compared to blood pressure shortly before administration.
Change in Radiochemical Safety Assessments
Change in heart rhythm on electrocardiogram (ECG)
Measured: At two hours post administration compared to same parameters shortly before administration.
Change in number of Subjects with prolonged PR interval greater than 20 mSec
Change in PR interval on electrocardiogram (ECG)
Measured: At two hours post administration compared to same parameters shortly before administration.
Change in number of subjects with QTc >440 mSec
Change in corrected QT interval on electrocardiogram (ECG).
Measured: At two hours post administration compared to same parameters shortly before administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start17 Sep 2020
- Primary completion29 Dec 2020
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro-Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- P. David Mozley, MD, Principal investigator, Cornell University Weill College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050800
- Sponsor's protocol ID
- 19-05020069
- Acronym
- [11C]Butanol
- Status last verified
- Jun 2021
- First submitted
- 6 Aug 2019
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data will be shared. The investigators will attempt to contribute the "raw" imaging data to a public archive for curation.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Safety of [Carbon-11]Butanol and Estimating the Test-Retest Variance in Measurements of Its Whole Body Biokinetics Under Zero-Biological-Change Conditions
- ClinicalTrials.gov ID
- NCT04050800
- Acronym / sponsor ID
- [11C]Butanol / 19-05020069
- Conditions
- Neuro-Degenerative Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 8 Aug 2019 (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.
This will be a Phase 1, open label, imaging study of radiochemical and radiation safety in healthy volunteers. Using positron emission tomography (PET) and in-line computed tomography (CT), the whole body (WB) biokinetics of Carbon-11 butanol will be quantified with serial scans acquired every 3 minutes for two hours. Vital signs (VS), electrocardiograms (ECGs) and clinical laboratory tests of intrernal organ function will be acquired before and at several timepoints after administration of the radiopharmaceutical. Radiation exposures will be estimated with the MIRD Formalism.
Detailed description
Vital signs (VSs) will be measured, electrocardiograms (ECGs) will be acquired, and blood will be sent to the clinical laboratory for safety assessments before a single dose, intravenous (IV) administration of 555 MBq of Carbon-11 butanol. VSs will be re-measured, ECGs will be acquired again, and more blood will be sent to the clinical laboratory for repeat safety assessments after 2 hours of whole body (WB) scanning. WB scanning will consist of imaging acquisition sweeps of 200 cm from head-to-toe over 180 secs (3 min). Up to 40 sweeps per imaging session will be performed. The subjects will then be given a rest period ("coffee break") for about two hours, after which the entire sequence of events will be repeated. The primary outcome measure will be related to radiation safety derived from the areas under the time-activity curves (AUCs) for internal organs. Co-primary clinical safety measures will include changes in VSs, ECG parameters such as the PR and corrected QT intervals, and clinical laboratory tests, such as proteins that reflect renal and hepatic function. Secondary endpoints will include the time-activity curves (TACs) and total volumes of distribution (VT) in several brain regions. The results should allow calculation of the repeatability coefficients (RCs) under zero-biological-change conditions. RC values will be essential for understanding whether future measurements of effect sizes in response to therapeutic maneuvers or the differences between groups are meaningful.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Drug: Carbon 11 ButanolSubjects will be administered two sequential doses of the radiopharmaceutical under nearly zero-biological-change conditions. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- able to give informed consent.
- age 18-89
- Subjectively healthy and, in the opinion of the investigators, likely to tolerate the imaging procedures and be compliant with the schedule of follow up telephone calls.
- Normal hemodynamic function. Systolic blood pressure and pulse must be higher than 120 mmHg and 60 beats per minute while sitting. At the discretion of the investigators, people who regularly engage in vigorous exercise more than four times per week may be enrolled if their systolic blood pressure and pulse are higher than 100 mmHg and 50 beats per minute while sitting.
- Unremarkable electrocardiograms, with PR intervals of less than 200 mSec and QTcF intervals (corrected with Frederica's method) of less than 440 mSec.
Key exclusion criteria (10 listed)
- Subjects may not be a member of a vulnerable population.
- Women may not be pregnant or breast feeding.
- History of multiple hypersensitivity reactions (atopia), as indicated by allergies to multiple medications, foods, and seasonal pollens.
- History, physical examination, or clinical laboratory tests suggestive of a condition, disorder, or disease that could adversely affect drug absorption, distribution, metabolism, or elimination (ADME) of the tracer, including chronic liver or renal failure.
- Positive urine toxicology screen for recreational drugs other than marijuana.
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 |
|---|---|---|
| Carbon 11 ButanolAlso: [11C]Butan-1-OlTwo sequential administrations of a PET tracer | Drug | Healthy Controls |
Primary outcome
Effective Dose (ED)
Time frame: Day 1, from the measurements of exposures during the first 2 hours post administration.
Fundamental radiation dose quantity in the International Commission on Radiological Protection (ICRP) system of radiological protection. Calculated with OLINDA-EXM software (OLINDA/EXM stands for Organ Level INternal Dose Assessment/EXponential Modeling).
5 secondary outcomes
Change in Radiochemical Safety Assessments
Time frame: Pulse at two hours post administration compared to pulse shortly before administration.
Change in Radiochemical Safety Assessments
Time frame: Blood pressure at two hours post administration compared to blood pressure shortly before administration.
Change in Radiochemical Safety Assessments
Time frame: At two hours post administration compared to same parameters shortly before administration.
Change in number of Subjects with prolonged PR interval greater than 20 mSec
Time frame: At two hours post administration compared to same parameters shortly before administration.
Change in number of subjects with QTc >440 mSec
Time frame: At two hours post administration compared to same parameters shortly before administration.
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 18 Jun 2021.
- Individual participant dataSharing planned: Yes. All de-identified data will be shared. The investigators will attempt to contribute the "raw" imaging data to a public archive for curation.
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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.
P. David Mozley, MD principal investigator
Cornell University Weill College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Carbon 11 Butanol in people with Neuro-Degenerative Disease, run by Weill Medical College of Cornell University 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 11 inclusion and 10 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 18 Jun 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Effective Dose (ED) (time frame: Day 1, from the measurements of exposures during the first 2 hours post administration.). 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 18 Jun 2021.