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Nuclear Imaging for Primary Aldosteronism
Phase 2
Waitlist Available
Led By Alexander Leung, MD
Research Sponsored by University of Calgary
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 it will be measured using adrenal vein sampling approximately the same time as the ceto pet/ct.
Awards & highlights
Study Summary
This trial is to compare a new tracer with PET and CT to the current gold standard for diagnosing Primary Aldosteronism.
Who is the study for?
This trial is for individuals with Primary Aldosteronism or Conn Syndrome, who have high blood pressure and an elevated adrenal renin ratio. They may also have low potassium levels and a visible adrenal nodule on imaging. It's not for those with severe kidney disease, uncontrolled high blood pressure or diabetes, certain adrenal gland disorders, liver anatomical diseases, pregnant or lactating women, people with pheochromocytoma, allergies to IV contrast, bleeding disorders, or those on long-term steroids.Check my eligibility
What is being tested?
[18-F]CETO is being tested in this study using PET/CT scans to differentiate between unilateral and bilateral forms of Primary Aldosteronism. The accuracy of CETO will be compared against Adrenal Vein Sampling (AVS), which is the current gold standard method.See study design
What are the potential side effects?
Potential side effects from [18-F]CETO used in PET/CT scans are generally minimal but can include reactions to the tracer such as rash or itching at the injection site. There might also be discomfort from lying still during the scan and exposure to radiation similar to other CT scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ it will be measured using adrenal vein sampling approximately the same time as the ceto pet/ct.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~it will be measured using adrenal vein sampling approximately the same time as the ceto pet/ct.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The measure is diagnostic test accuracy (expressed as sensitivity, specificity, positive predictive value, and negative predictive value) for CETO PET/CT using adrenal vein sampling as a reference standard.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CETOExperimental Treatment1 Intervention
The consented participants will receive the [18-F] CETO through the IV and a PET/CT scan afterwards.
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,124 Total Patients Enrolled
Alexander Leung, MDPrincipal InvestigatorUniversity of Calgary
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have high levels of a hormone called renin in your adrenal glands.I have low potassium levels and/or a significant adrenal gland nodule.My kidney function is low (eGFR <40).I am allergic to IV contrast, have a bleeding disorder, or take steroids regularly.I do not have uncontrolled high blood pressure, severe diabetes, abnormal cortisol levels, or liver disease.I have high blood pressure.I am not pregnant, breastfeeding, or have a tumor called pheochromocytoma.
Research Study Groups:
This trial has the following groups:- Group 1: CETO
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has [18-F]CETO been cleared by the FDA for therapeutic use?
"While [18-F]CETO is still in Phase 2 trials, meaning that there is not yet data supporting efficacy, there is evidence suggesting that it is safe."
Answered by AI
Are there any available openings for this clinical trial?
"Unfortunately, this specific study is no longer enrolling patients. According to the information on clinicaltrials.gov, which was last updated on July 22nd, 2022, this trial stopped recruiting on an undisclosed date. Although this particular trial has ended recruitment, there are 13 other trials that remain open to new enrollees."
Answered by AI
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