Hormone Monitoring for Hyperparathyroidism

(PEREGRINE Trial)

Overseen By Phillip Staibano, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Pregnant, Breastfeeding, Primary hyperparathyroidism, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether monitoring hormone levels during parathyroid surgery can improve outcomes for individuals with certain types of hyperparathyroidism, a condition where the parathyroid glands produce excess hormone. Researchers aim to determine if using these hormone levels to guide surgery is feasible for a larger study. Participants will undergo surgery either with intraoperative parathyroid hormone monitoring at different time points or without it. Those with persistent high parathyroid hormone levels due to kidney disease or recurrent issues might be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could enhance surgical outcomes.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that intraoperative parathyroid hormone monitoring is safe for guiding surgery?

Research has shown that intraoperative parathyroid hormone (IOPTH) monitoring during parathyroid surgery is generally safe. Studies have found that problems related to IOPTH monitoring are rare. No strong evidence indicates serious safety issues with IOPTH use. Instead, it helps surgeons determine if enough parathyroid tissue has been removed, reducing the likelihood of needing another surgery. Surgeries using IOPTH have a lower failure rate compared to those without it, and the monitoring does not add significant risks to the procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for intraoperative parathyroid hormone (IOPTH) monitoring in hyperparathyroidism surgery because it could refine surgical precision and outcomes. Unlike standard procedures that may not utilize hormone monitoring, this method involves checking parathyroid hormone levels at specific intervals—10, 15, 20, and 25 minutes—after removing problematic tissue. This approach could help surgeons determine if additional tissue needs to be removed, potentially reducing the risk of persistent disease. By tailoring surgery more precisely to hormone levels, this trial aims to enhance the effectiveness and safety of hyperparathyroidism treatment.

What evidence suggests that this trial's treatments could be effective for hyperparathyroidism?

This trial will compare different approaches to intraoperative parathyroid hormone (IOPTH) monitoring during surgery. Studies have shown that IOPTH monitoring can greatly improve the chances of success. A drop in parathyroid hormone levels by at least 50% within 10 to 20 minutes after removing the problematic gland strongly indicates successful surgery. Research shows that surgeries using IOPTH monitoring are more successful than those without it. For instance, one study found that surgeries without IOPTH had a success rate of about 93.3%, but this rate improved with IOPTH use. These findings suggest that IOPTH monitoring is a helpful tool for achieving better results in parathyroid surgery. Participants in this trial will be randomized into different arms, including those with no IOPTH monitoring and those with IOPTH monitoring at various time intervals, to assess the effectiveness of each approach. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a candidate for surgery to remove part of my parathyroid or my entire thyroid.

I have been diagnosed with a type of hyperparathyroidism.

Exclusion Criteria

Pregnant or breastfeeding women

Unable to provide written consent to be participant in study

I am having surgery to remove parathyroid glands due to primary hyperparathyroidism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Pre-Surgery

Participants are randomized into one of the five arms and undergo pre-surgical assessments including quality of life and cognitive questionnaires, and bloodwork.

2 weeks

Surgery

Participants undergo parathyroid surgery with or without IOPTH monitoring based on randomization. Surgery includes intraoperative monitoring and potential re-exploration based on IOPTH criteria.

1 day

Post-Surgery Follow-up

Participants are monitored for surgical outcomes, complications, and recurrent hyperparathyroidism. Follow-up includes bloodwork and questionnaires at 1 month, 3 months, and 6 months post-surgery.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative Parathyroid Hormone Monitoring

Trial Overview 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.

How Is the Trial Designed?

Group I: 25 minute arm Experimental Treatment 1 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 arm Experimental Treatment 1 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 arm Experimental Treatment 1 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 arm Experimental Treatment 1 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 arm Active Control 1 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.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5801330/

Clinical usefulness of intraoperative parathyroid hormone ... A fall in PTH levels from baseline by at least 50% in 10 minutes after removing the hyper functioning parathyroid gland was used to define success according to ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0011384025002163

Intraoperative parathyroid hormone monitoring criteria in ... With regards to IOPTH criteria, these studies typically evaluated Miami criteria or a minimum 70% IOPTH decrease at 10 minutes from completion ...

3. nature.com nature.com/articles/s41598-022-07380-4

Interpretation of intraoperative parathyroid hormone ... The data emerging from our study in favor of extending ioPTH monitoring to 20 min after baseline detection appeared to be quite robust. Closer ...

4. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.1024350/full

Contribution of intraoperative parathyroid hormone ... According to our results, the success rate of surgery without ioPTH was 93.3% and the surgical success rate could be increased with the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06542315

Intraoperative Parathyroid Hormone Monitoring to Guide ... Secondary efficacy outcomes will include operating room time, renal graft outcomes, renal function, cardiovascular outcomes, hospital admission and rate of re- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12273077/

Intraoperative parathyroid hormone monitoring to guide ... Safety outcomes. Adverse events and serious adverse events ... We did not arrange for a data safety and monitoring board for this ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S174391912100176X

The role of Rapid Intraoperative Parathyroid Hormone ... The rate of surgical failure was 3.1% in the case group (range 0–10.2%) and 5.6% in the control group (range 0–10.9%), with an overall rate of surgical failure ...

8. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/article-abstract/2827787

Intraoperative Parathyroid Hormone Monitoring Criteria in ... This meta-analysis evaluates and ranks the diagnostic properties of intraoperative parathyroid hormone monitoring criteria used during ...