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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ga-68 Galmydar

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring myocardial perfusion imaging, pharmacological stress, biodistribution, positron emission tomography, myocardial blood flow

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dosimetry Group

Arm Description

Normal 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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

Clinically Significant Change in Heart Rate.

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

Clinically Significant Change in Respiratory Rate.

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

Clinically Significant Elevation in Oral Temperature

Oral temperature of >100 degrees F.

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).

Clinically Significant Change in EKG Showing New Bradycardia

New heart rate < 40 BPM.

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.

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.

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.

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.

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.

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.

Clinically Significant Change in Hematocrit (Hct)

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

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.

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.

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.

Full Information

NCT ID

NCT05280782

First Posted

January 18, 2022

Last Updated

August 11, 2023

Sponsor

Washington University School of Medicine

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05280782

Brief Title

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

Acronym

GALMYDAR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

January 5, 2022 (Actual)

Primary Completion Date

May 1, 2022 (Actual)

Study Completion Date

May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Washington University School of Medicine

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

myocardial perfusion imaging, pharmacological stress, biodistribution, positron emission tomography, myocardial blood flow

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dosimetry Group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ga-68 Galmydar

Other Intervention Name(s)

IND 157468

Intervention Description

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

Primary Outcome Measure Information:

Title

Organ Dosimetry

Description

Time Frame