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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot clinical is to determine the feasibility of a fully powered clinical trial to determine the effectiveness of intraoperative parathyroid hormone (IOPTH) criteria in guiding surgery for secondary and tertiary hyperparathyroidism. The main question it aims to answer is: Is a fully powered trial investigating the role for IOPTH criteria in secondary and tertiary hyperparathyroidism feasible? The comparison group is surgery not guided by IOPTH. Participants will be randomized to undergo parathyroid surgery with one of four IOPTH criteria or a control arm that does not use IOPTH. All recruited patients are asked to complete quality of life and cognitive questionnaires, in addition to bloodwork during the study period.

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 data supports the effectiveness of the treatment Intraoperative Parathyroid Hormone Monitoring for Hyperparathyroidism?

Intraoperative parathyroid hormone monitoring can help ensure the success of surgery for hyperparathyroidism by confirming the removal of problematic glands, potentially improving cure rates and simplifying care. However, there are concerns about false-negative results and the cost of point-of-care testing. ^{1 2 3 4 5}

Is intraoperative parathyroid hormone monitoring safe for humans?

The research does not specifically mention safety concerns related to intraoperative parathyroid hormone monitoring, but it highlights challenges in interpreting results, such as false negatives and 'PTH spikes' (sudden increases in hormone levels during surgery), which may complicate the procedure. ^{1 5 6 7 8}

How does intraoperative parathyroid hormone monitoring differ from other treatments for hyperparathyroidism?

Intraoperative parathyroid hormone monitoring is unique because it allows surgeons to measure hormone levels during surgery to confirm the successful removal of problematic parathyroid tissue, reducing operation time and failure rates. This real-time feedback is not typically available with other treatments for hyperparathyroidism. ^{4 6 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Validity and limits of intraoperative parathyroid hormone monitoring during minimally invasive parathyroidectomy: a 10-year experience. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Successful parathyroidectomy guided by intraoperative parathyroid hormone monitoring for primary hyperparathyroidism is preserved in mild and moderate renal insufficiency. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Impact of intraoperative parathyroid hormone monitoring on the management of patients with primary hyperparathyroidism. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Intra-operative parathyroid hormone monitoring using a laboratory based multichannel analyser. [2008]

5. England pubmed.ncbi.nlm.nih.gov

Focused parathyroidectomy without intra-operative parathyroid hormone monitoring for primary hyperparathyroidism: results in a low-volume hospital. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Clinical impact of two different intraoperative parathyroid hormone assays in primary and renal hyperparathyroidism. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Risk factors for "PTH spikes" during surgery for primary hyperparathyroidism. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Primary Hyperparathyroidism and Intraoperative Parathyroid Hormone Monitoring: Application of a Modified Interpretation in Patients With "Parathyroid Hormone Spikes". [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Intraoperative decay profile of intact (1-84) parathyroid hormone in surgery for renal hyperparathyroidism--a consecutive series of 80 patients. [2004]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Intraoperative chemiluminometric assay for simplified localization of parathyroid adenomas during surgery for primary hyperparathyroidism. [2008]

11. United States pubmed.ncbi.nlm.nih.gov

The influence of intraoperative parathyroid hormone monitoring on the surgical management of hyperparathyroidism. [2016]