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Completed

NCT Number: NCT05280782

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Ga-68 Galmydar

Drug

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

Other names: IND 157468

Primary outcomes

  1. Organ Dosimetry

    Time frame: 6 hours from 68Ga-Galmydar injection

    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.

  2. Biodistribution

    Time frame: 6 hours from 68Ga-Galmydar injection

    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.

  3. Total Effective Dose of the Radiotracer

    Time frame: 6 hours from 68Ga-Galmydar injection

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

Secondary outcomes

  1. Clinically Significant Change in Blood Pressure.

    Time frame: 6 hours from 68Ga-Galmydar injection

    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.

  2. Clinically Significant Change in Heart Rate.

    Time frame: 6 hours from 68Ga-Galmydar injection

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

  3. Clinically Significant Change in Respiratory Rate.

    Time frame: 6 hours from 68Ga-Galmydar injection

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

  4. Clinically Significant Elevation in Oral Temperature

    Time frame: 6 hours from 68Ga-Galmydar injection

    Oral temperature of >100 degrees F.

  5. Clinically Significant Change in EKG Showing New AV Block

    Time frame: 6 hours from 68Ga-Galmydar injection

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

  6. Clinically Significant Change in EKG Showing New Bradycardia

    Time frame: 6 hours from 68Ga-Galmydar injection

    New heart rate < 40 BPM.

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

    Time frame: 6 hours from 68Ga-Galmydar injection

    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.

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

    Time frame: 6 hours from 68Ga-Galmydar injection

    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.

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

    Time frame: 6 hours from 68Ga-Galmydar injection

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

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

    Time frame: 6 hours from 68Ga-Galmydar injection

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

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

    Time frame: 6 hours from 68Ga-Galmydar injection

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

  12. Clinically Significant Change in Hemoglobin (Hgb)

    Time frame: 6 hours from 68Ga-Galmydar injection

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

  13. Clinically Significant Change in Hematocrit (Hct)

    Time frame: 6 hours from 68Ga-Galmydar injection

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

  14. Clinically Significant Change in Platelets

    Time frame: 6 hours from 68Ga-Galmydar injection

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

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

    Time frame: 6 hours from 68Ga-Galmydar injection

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

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

    Time frame: 6 hours from 68Ga-Galmydar injection

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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: GALMYDAR

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2022
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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