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Hormone Therapy

Hormone Monitoring for Hyperparathyroidism (PEREGRINE Trial)

N/A
Waitlist Available
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Candidate for subtotal parathyroidectomy or total thyroidectomy with or without autotransplantation
Tertiary hyperparathyroidism and/or recurrent hyperparathyroidism OR secondary hyperparathyroidism diagnosed with any stage of chronic kidney disease
Must not have
Undergoing parathyroidectomy for primary hyperparathyroidism
Undergoing revision parathyroidectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to the end the trial at 6 months
Awards & highlights

Summary

"This trial aims to see if using intraoperative parathyroid hormone (IOPTH) criteria during surgery for secondary and tertiary hyperparathyroidism is feasible. Patients will be randomly assigned to have surgery

Who is the study for?
This trial is for individuals with hyperparathyroidism, which causes high calcium levels and can lead to bone and kidney problems. Participants should be scheduled for parathyroid surgery. There are specific criteria they must meet to join the study, but these have not been detailed here.
What is being tested?
The study tests if monitoring parathyroid hormone levels during surgery (IOPTH) helps guide the procedure better than surgeries without this monitoring. Patients will be randomly assigned to one of four IOPTH-guided surgery groups or a control group without IOPTH guidance.
What are the potential side effects?
Since the intervention involves a surgical procedure, potential side effects may include typical surgical risks such as infection, bleeding, or reaction to anesthesia. Specific side effects related to IOPTH monitoring are not provided.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a candidate for surgery to remove part of my parathyroid or my entire thyroid.
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I have been diagnosed with a type of hyperparathyroidism.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am having surgery to remove parathyroid glands due to primary hyperparathyroidism.
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I am scheduled for a second parathyroid surgery.
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I am having a minimally invasive surgery on my parathyroid.
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I cannot attend all required study follow-up visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the end the trial at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end the trial at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Randomization rate
Secondary study objectives
Blinding effectiveness
Follow-up completion
Surgeon compliance and crossover
+1 more
Other study objectives
Chronic kidney disease progression, cardiovascular death, or renal death (composite outcome)
Cognitive function
Emergency room visits and hospital readmission rates
+11 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: 25 minute armExperimental Treatment1 Intervention
Surgery for patients randomized to this arm will need to use IOPTH monitoring. Surgeons in this arm will decide to end surgery or perform surgical re-exploration if the IOPTH level at 25 minutes following ligation of all hyperfunctioning parathyroid tissue is \>=50% from the highest pre-incision or pre-excision baseline IOPTH level.
Group II: 20 minute armExperimental Treatment1 Intervention
Surgery for patients randomized to this arm will need to use IOPTH monitoring. Surgeons in this arm will decide to end surgery or perform surgical re-exploration if the IOPTH level at 20 minutes following ligation of all hyperfunctioning parathyroid tissue is \>=50% from the highest pre-incision or pre-excision baseline IOPTH level.
Group III: 15 minute armExperimental Treatment1 Intervention
Surgery for patients randomized to this arm will need to use IOPTH monitoring. Surgeons in this arm will decide to end surgery or perform surgical re-exploration if the IOPTH level at 15 minutes following ligation of all hyperfunctioning parathyroid tissue is \>=50% from the highest pre-incision or pre-excision baseline IOPTH level.
Group IV: 10 minute armExperimental Treatment1 Intervention
Surgery for patients randomized to this arm will need to use IOPTH monitoring. Surgeons in this arm will decide to end surgery or perform surgical re-exploration if the IOPTH level at 10 minutes following ligation of all hyperfunctioning parathyroid tissue is \>=50% from the highest pre-incision or pre-excision baseline IOPTH level.
Group V: No IOPTH monitoring armActive Control1 Intervention
Surgery for patients randomized to this arm will not require guidance with any IOPTH monitoring. These will be allowed to use frozen section analysis, if deemed appropriate by the surgeon.

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
906 Previous Clinical Trials
2,613,181 Total Patients Enrolled
~40 spots leftby Apr 2026
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