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Coronary Artery DiseaseEarly Phase 1GALMYDARNCT05280782

Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging-Dosimetry Group

A Early Phase 1 study testing Ga-68 Galmydar in people with Coronary Artery Disease, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single center, early phase 1 clinical imaging study designed to assess the dosimetry of 68Ga-Galmydar for PET/CT imaging. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Coronary Artery Disease
What is being tested?
Ga-68 Galmydar
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
5 Jan 2022to 1 May 2022
Phase
Early Phase 1
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 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy men and women, 18-99 years of age and any race

Who cannot join

  • Inability to receive and sign informed consent;
  • Positive urine screen for drugs of abuse at screening or before dosing or over-the- counter drug use or herbal preparations within the 2-week period prior to enrollment;
  • Participation in another research study with a study drug, including a diagnostic or therapeutic radiopharmaceutical, to be administered during this study or which was or will be administered within 10 hall-lives of the radiopharmaceutical.
  • Severe claustrophobia;
  • Pregnant or breastfeeding.
  • Body mass index < 18 kg/m2 or > 40 kg/m2.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging

This study is a single center, early phase 1 clinical imaging study designed to assess the dosimetry of 68Ga-Galmydar for PET/CT imaging.

Read the detailed description

The objective is to evaluate dosimetry, biodistribution, safety, and imaging characteristics following a single 68Ga-Galmydar injection in normal healthy volunteers. Healthy adult normal volunteers (n=8, 4 males; 4 females) will undergo whole-body imaging (dosimetry group).

Healthy adult normal volunteers (n=8, 4 males; 4 females) will receive a single intravenous Ga-68 Galmydar administration of 8 mCi ± 20% (6.4-9.6 mCi) with a mass of ≤ 10 µg followed by whole-body PET/CT imaging.

Being tested
Ga-68 Galmydar
Keywords
myocardial perfusion imaging, pharmacological stress, biodistribution, positron emission tomography, myocardial blood flow
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Ga-68 GalmydarDrug

    Also called IND 157468

    Single intravenous injection of the PET radiotracer 68Ga-Galmydar.

Study groups in NCT05280782
Study groupRoleWhat they receive
Dosimetry GroupExperimentalNormal Volunteers will receive a single intravenous injection of 8 mCi ± 20% (6.4-9.6 mCi) of the PET radiotracer 68Ga-Galmydar. They will undergo whole-body PET/CT imaging at three-time points, immediately post [68Ga]Galmydar injection, and at 2 hours and 4 hours after injection. Serum chemistries, complete blood count, EKG, vital signs, and physical examination will performed before injection and at the completion of the examinations.
Receives: Drug: Ga-68 Galmydar

What is being measured

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

  1. Organ Dosimetry

    On whole body PET/CT, regions of interest are drawn on the liver, spleen, kidney, lumbar vertebrae and left ventricle of the heart. Average organ dose is measured and compared. Organ radiation dose is measured and reported in rad/mCi.

    Measured: 6 hours from 68Ga-Galmydar injection

  2. Biodistribution

    The organ with the highest radiation dose in rad/mCi is determined to be the dose-critical organ. The organ showing the largest dose is the gallbladder wall.

    Measured: 6 hours from 68Ga-Galmydar injection

  3. Total Effective Dose of the Radiotracer

    Total Effective Dose of the radiotracer is calculated using ICRP-60 organ weights and is reported in rem/mCi.

    Measured: 6 hours from 68Ga-Galmydar injection

Secondary outcomes (16)

  1. Clinically Significant Change in Blood Pressure.

    The following variables are considered clinically significant if changes occur from baseline. A systolic BP of < 90 or > 160 mmHg or a diastolic BP of < 50 or > 100 mmHg or a 20 mmHg change from baseline in the SBP or DBP.

    Measured: 6 hours from 68Ga-Galmydar injection

  2. Clinically Significant Change in Heart Rate.

    A heart rate of < 50 BPM or > 100 or a 20 BPM change from baseline.

    Measured: 6 hours from 68Ga-Galmydar injection

  3. Clinically Significant Change in Respiratory Rate.

    A respiratory rate of < 12 or > 20 breaths/min.

    Measured: 6 hours from 68Ga-Galmydar injection

  4. Clinically Significant Elevation in Oral Temperature

    Oral temperature of >100 degrees F.

    Measured: 6 hours from 68Ga-Galmydar injection

  5. Clinically Significant Change in EKG Showing New AV Block

    A change in EKG showing new AV Block (Type 1 or Type 2), Mobitz 2:1, or QTc ≥ 500ms).

    Measured: 6 hours from 68Ga-Galmydar injection

  6. Clinically Significant Change in EKG Showing New Bradycardia

    New heart rate < 40 BPM.

    Measured: 6 hours from 68Ga-Galmydar injection

  7. Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2

    Serum chemistries (sodium, potassium, chloride, CO2) measured in mmol/L. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  8. Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin

    Serum chemistries (glucose, calcium creatinine, BUN, total bilirubin), measured in mg/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  9. Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.

    Serum chemistries (total protein, albumin), measured in g/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  10. Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST

    Serum chemistries (alkaline phosphatase), measured in U/L. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  11. Clinically Significant Change in White Blood Cell Count (WBC)

    White blood cell count measured in WBC/mm3 blood. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  12. Clinically Significant Change in Hemoglobin (Hgb)

    Hgb measured in g/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  13. Clinically Significant Change in Hematocrit (Hct)

    Hct measured in %. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  14. Clinically Significant Change in Platelets

    Platelets measured in platelets/mm3 blood. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  15. Clinically Significant Change in Red Blood Cell Count (RBC)

    RBC measured in million/mm3. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

  16. Clinically Significant Change in Mean Corpuscular Volume (MCV)

    MCV measured in µm3. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values.

    Measured: 6 hours from 68Ga-Galmydar injection

Timeline

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

  1. First posted15 Mar 2022
  2. Study start5 Jan 2022
  3. Primary completion1 May 2022
  4. Study completion1 May 2022

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05280782
Sponsor's protocol ID
202107042
Other IDs
IND 157468, R01HL142297
Acronym
GALMYDAR
Status last verified
Aug 2023
First submitted
18 Jan 2022
Last updated
8 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sivapackiam J, Laforest R, Sharma V. 68Ga[Ga]-Galmydar: Biodistribution and radiation dosimetry studies in rodents. Nucl Med Biol. 2018 Apr;59:29-35. doi: 10.1016/j.nucmedbio.2017.11.008. Epub 2017 Dec 1.

    PubMed 29454148

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ga-68 Galmydar in people with Coronary Artery Disease, run by Washington University School of Medicine 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 1 inclusion and 6 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 8 Sep 2023. 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?

Yes. Results are posted in the registry (first posted 8 Sep 2023). 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?

Organ Dosimetry (time frame: 6 hours from 68Ga-Galmydar injection). The study lists 3 primary outcomes in all. 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 NCT05280782, which also lists 1 linked publication.

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 8 Sep 2023.

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