Low-Dose PET/CT Imaging Techniques

Overseen By Michael V Knopp, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Pregnancy, Prisoners, Informed consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

190 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess new low radiation dose techniques for clinical PET/CT scans through intra-individual comparison between a clinical, standard dose scan and a low-dose scan, completed within one week of each other.

Research Team

Michael V Knopp, MD, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for adults over 18 who are scheduled for a standard PET/CT scan and can lie flat during the procedure. Women able to have children must meet specific requirements for imaging agents and CT exams. Pregnant or breastfeeding individuals, prisoners, or those unable to consent are excluded.

Inclusion Criteria

I am scheduled for a PET/CT scan as part of my routine care.

For female patients of child-bearing potential, the OSUWMC requirements for receiving the standard of care PET imaging agent and CT examination needs to be met

Exclusion Criteria

I am unable to understand or sign the consent form.

I cannot lie flat for long periods.

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PET/CT scans with both standard and low FDG doses for comparison

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-5 years

Treatment Details

Interventions

• PET/CT scan with 13 mCi radiation dose
• PET/CT scan with 2.5 mCi radiation dose
• PET/CT scan with 5 mCi radiation dose
• PET/CT Scan with 6.5 mCi radiation dose
• PET/CT Scan with not yet determined radiation dose

Trial Overview The study is testing new low-dose radiation techniques for PET/CT scans by comparing them with the current standard dose. Each participant will receive both a standard dose scan and one of several lower doses within one week.

Participant Groups

Group I: Sub-Study F Experimental Treatment 2 Interventions

Patients receive PET/SCAN using system that did not show equivalence in Sub-Study A-C

Group II: Sub-Study E Experimental Treatment 2 Interventions

Patients receive lower radiation dose on Vereos 128 digital PET/CT

Group III: Sub-Study D Experimental Treatment 2 Interventions

Patients receive PET/CT scan on Vereos 128 digital PET/CT

Group IV: Sub-Study C Experimental Treatment 2 Interventions

Patients receive PET/CT scan on Discovery PET/CT

Group V: Sub-Study B Experimental Treatment 2 Interventions

Patients receive PET/CT scan on Biograph mCT

Group VI: Sub-Study A Experimental Treatment 2 Interventions

Patients receive PET/CT scan on Gemini Astonish PET/CT

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Ohio Third Frontier

Collaborator

Trials

6

Recruited

690+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+