PTeye for Hypercalcemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Michigan, Ann Arbor, MI
Hypercalcemia+7 More
PTeye - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a device can help surgeons find parathyroid glands during parathyroidectomy.

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Eligible Conditions

  • Hypercalcemia
  • Parathyroid Cancer
  • Primary Hyperparathyroidism (PHPT)
  • Parathyroid Adenomas
  • Parathyroid Adenoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether PTeye will improve 2 primary outcomes and 13 secondary outcomes in patients with Hypercalcemia. Measurement will happen over the course of Immediate. During PTx procedure..

Hour 72
Number of nights spent in the hospital after parathyroidectomy
Month 6
Number of patients who have had repeat parathyroidectomy (PTx) procedure
6 months after surgery
Blood calcium levels
Parathyroid hormone (PTH) levels
Collected immediately following surgery
Duration of Surgery in minutes
Number of frozen section analysis performed (by case)
Frozen results collected immediately after surgery.
Percent of frozen sections confirmed as parathyroid tissue
Immediate. During PTx procedure
Average number of minutes taken to identify first parathyroid gland
Average number of minutes taken to identify last parathyroid gland
Immediate. During PTx procedure.
Minutes taken for intraoperative parathyroid hormone (PTH) to normalize
Day 7
Permanent histology - parathyroid tissue, cellularity, gland weight
Time Frame: Immediate. During total thyroidectomy procedure.
Overall number of parathyroid glands identified.
up to 30 days
Frequency of postoperative (within 30 days) Emergency Room visits or hospitalization
Number of postsurgical complications
up to 6 months
Percent of repeat surgeries due to high calcium

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
PTeye
1 of 2
Active Control
Experimental Treatment

This trial requires 160 total participants across 2 different treatment groups

This trial involves 2 different treatments. PTeye is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

PTeye
Device
The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery.
Standard of CareThe surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months for reporting.

Who is running the study

Principal Investigator
P. G.
Prof. Paul Gauger, Ambulatory Care Clinical Chief, William J Fry Professor of Surgery and Professor of Surgery, Medical School
University of Michigan

Closest Location

The University of Michigan - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People with primary hyperparathyroidism who are having surgery to remove their parathyroid glands are at risk for low blood calcium levels show original
Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery

Patient Q&A Section

Has pteye proven to be more effective than a placebo?

"Data from a recent study of this study suggest that PTE may provide a clinically meaningful improvement over a placebo (difference = 0.8 SD; P =.01). It would appear that patients who receive no treatment for parathyroid adenoma during their lifetime derive a greater benefit from surgery than patients whose parathyroid glands are removed later in life. Data from a recent study should reassure patients and their physicians that there is an urgent need to collect further data on patients who are at risk for developing secondary hyperparathyroidism and who are currently awaiting surgical intervention. Additional studies are warranted to determine whether PTE is superior to the current standard of care." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating parathyroid adenoma?

"Currently, surgery is the 'gold standard' for management of primary hyperparathyroidism. Fortunately, surgical resection is still associated with low rates of recurrence. Newer treatments such as minimally invasive parathyroidectomy offer significant advantages over open surgery, including shorter hospital stays and reduced rates of postoperative complications." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in pteye for therapeutic use?

"The effectiveness of pteye is still under evaluation. Current research has been focusing on new ways to better understand the disease process, refine diagnostic techniques, and develop improved therapy methods. Currently, there are no FDA approved indications for pteye, but it may become an important tool in treating end stage renal disease (ESRD)." - Anonymous Online Contributor

Unverified Answer

Is pteye typically used in combination with any other treatments?

"Pteye has been used with all 3 types of treatments except for cryoablation alone or cryoablation followed by radiofrequency ablation. There was no difference between pteye and other treatments for overall efficacy, but pteye had a shorter time to resolution of pain and an earlier return to normal activities. Pteye may be useful for treating parathyroid adenomas." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of pteye?

"The most common side effects were nausea (46%) and headache (41%), but dizziness (38%), headache (34%), rash (33%), constipation (32%), fatigue (31%), and dry skin (30%). There were no statistically significant differences between men and women." - Anonymous Online Contributor

Unverified Answer

Does parathyroid adenoma run in families?

"Parathyroid adenomas run in multiple families. A number of other endocrine tumors have been reported to run in families; however, this is the first report of familial parathyroid adenomas. Subjects with parathyroid adenomas should be screened for prolactin secretion syndrome and hypercalcemia from any adrenocortical tumor; metachronous thyroid disease; and prothrombin G20210A mutation." - Anonymous Online Contributor

Unverified Answer

How quickly does parathyroid adenoma spread?

"Although it is difficult to predict how quickly parathyroid adenoma will spread, we believe that surgeons must be aware of the possibility of metastatic spread from parathyroid adenomas even when they appear benign on endoscopic examination. We think that this observation deserves consideration when deciding whether to perform parathyroidectomy in patients with symptomatic parathyroid adenoma." - Anonymous Online Contributor

Unverified Answer

How does pteye work?

"The PTEY device has been used as an effective and convenient alternative to PTH in patients undergoing parathyroidectomy. This device has proven to be safe and effective in reducing post-operative hypocalcemia and PTH levels without any other adverse effects. PTEY appears to be a useful pre-operative adjunct for parathyroidectomy." - Anonymous Online Contributor

Unverified Answer

What is the latest research for parathyroid adenoma?

"Parathyroid adenoma is a benign tumor that affects most women during their middle age. Women are more likely to have a larger gland size than men and there is also a higher frequency of bilateral disease. Bilateral disease is associated with more frequent calcification and more often it occurs in the lower half of the neck. In our experience unilateral disease has been found in patients younger than 50 years old and bilateral disease in older people (>50 years old). Parathyroid adenomas usually occur in solitary glands but multiple glands occur in about 20% to 25% of cases. Most lesions are less than 2 cm in diameter and are found incidentally on ultrasound scan performed for other reasons." - Anonymous Online Contributor

Unverified Answer

What is parathyroid adenoma?

"Parathyroid gland tumors are uncommon, but may be confused with local (kidney) neoplasms that cause flank pain. The first step often involves determining whether a tumor is benign. If a parathyroid adenoma is identified, surgical removal is indicated, because this lesion is a rare cause of chronic renal failure. Parathyroid adenomas occur most commonly after age 50, and require close monitoring because of an increased risk of developing severe hypercalcemia (high blood levels of calcium and phosphate) and bone fractures. Parathyroid adenomas that remain undetected usually grow slowly, and rarely metastasize." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for parathyroid adenoma?

"Parathyroid adenomas have a good prognosis and may be treated conservatively with follow-up imaging (CT scan or MRI). Patients with recurrent symptoms should undergo surgery. The 5-year disease free survival rate is 96% for primary adenoma, 100% for MEN1 associated adenomas and 89% for sporadic adenoma. Patients with MEN1 associated adenoma have a higher risk of developing malignancy within 20 years after diagnosis. Patients with MEN1 associated adenoma should be followed up at regular intervals over time." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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