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FDG for Healthy Subjects

Phase 1 & 2
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing different ways to prepare for an FDG PET/CT scan, which is a routine test to evaluate heart inflammation. The standard preparation includes a ketogenic diet and fasting overnight, but it's not clear if this is the most effective method. Up to 3 different methods of preparation will be tested to see which works best.

Eligible Conditions
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparing the myocardial glucose suppression in Ketogenetic diet vs. external Ketone supplement by looking at the FDG uptake using PET/CT
Secondary outcome measures
The optimal duration of ketosis to produce myocardial suppression by looking at the FDG uptake using PET/CT by comparing the data out of 1 day keto diet Arm versus 3 days Keto diet Arm
Understanding the relationship between serum β-hydroxybutyrate (BHB) levels and myocardial glucose by looking at the FDG uptake using PET/CT by comparing the data out of keto diet Arm versus Ketone supplement Arm.
comparing the transthoracic echocardiogram changes before and after the Ketone supplement drink to assess the effect of Ketone supplement

Side effects data

From 2014 Phase 2 trial • 26 Patients • NCT00963807
11%
Death
11%
Dyspnea
11%
Neutropenic Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Ketogenic diet - 72 hoursExperimental Treatment2 Interventions
Subjects will then undergo FDG PET/CT after 3 day of dietary modification (ketogenic diet for at least 9 meals) and 12 hours of fasting prior to FDG injection.
Group II: Ketogenic diet - 24 hoursExperimental Treatment2 Interventions
Subjects will undergo FDG PET/CT after 1 day of dietary modification (ketogenic diet for at least 3 meals) and 12 hours of fasting prior to FDG injection.
Group III: Exogenous ketone esterExperimental Treatment2 Interventions
Subjects will undergo FDG PET/CT after 1 dose of ketone drink administration after 12 hours of fasting prior to FDG injection. The dosing of ketone drink administration (approximately 65 mL) will be weight based (714 mg/kg), which is crucial to replicating ketone levels between participants. The KE drink will be administered approximately 45 minutes prior to FDG injection as concentrations of ~3 mmol/L are reached within 60 minutes . By way of comparison, website marketing of the commercial drink recommends ingestion 30 minutes prior to athletic performance. We will also perform echocardiography immediately before and 30 minutes after the drink.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FDG
2014
Completed Phase 2
~150

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,068 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost threshold of participants that this clinical trial can accommodate?

"Affirmative. Clinicaltrials.gov hosts information that confirms this clinical trial is still searching for suitable candidates. The study was first posted on 5th January 2020, and has since been updated on 15th July of the same year. This medical experiment requires 20 participants from one location to take part in it."

Answered by AI

Are there any available slots in this trial for participants?

"As indicated by clinicaltrials.gov, this medical study is currently calling for participants to join; the initial posting was on May 1st 2020 and a recent edit took place on July 15th 2020."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
New Jersey
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging
2020. "Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04275453.
~4 spots leftby Apr 2025
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