PTeye for Hypoparathyroidism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Michigan, Ann Arbor, MI
Hypoparathyroidism+8 More
PTeye - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether the use of near infrared autofluorescence (NIRAF) detection with a 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx) is

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Eligible Conditions

  • Hypoparathyroidism
  • Neoplasms by Site
  • Parathyroid Diseases
  • Cancer
  • Endocrine Gland Neoplasms
  • Thyroid Diseases
  • Thyroid Adenoma
  • Endocrine System Diseases
  • Head Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether PTeye will improve 2 primary outcomes and 12 secondary outcomes in patients with Hypoparathyroidism. Measurement will happen over the course of Collected immediately following surgery.

Hour 72
Number of nights spent in the hospital after total thyroidectomy
6 months after surgery
Blood parathyroid hormone (PTH) levels
Collected immediately following surgery
Duration in minutes of surgery
Number of frozen section analysis performed(By case)
Frozen results collected immediately after surgery.
Percent of frozen sections confirmed as parathyroid tissue
Immediate (During total thyroidectomy procedure)
Overall number of parathyroid glands identified.
Day 10
Number of inadvertently resected parathyroid glands
Immediate. During total thyroidectomy procedure
Number of auto-transplanted parathyroid glands
Day 7
Permanent histology reports of all excised tissues
Month 3
Duration of calcium and/or Vitamin D supplementation
Number of postsurgical complications
Hour 24
Blood calcium levels
Month 3
History of calcium and/or Vitamin D supplementation
up to 30 days
Frequency of Emergency Room (ER) visits or hospitalization due to low blood calcium within 30 days of surgery

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 total thyroidectomy procedure.
Standard of CareThe surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying 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: immediate. during total thyroidectomy procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly immediate. during total thyroidectomy procedure 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:
Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland).
Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy.

Patient Q&A Section

Can parathyroid diseases be cured?

"The main goal of treatment is not necessarily cure but, rather, long-term cure or remission. Surgical resection may reduce symptoms in 1/4 of patients and even long-term cure (about 20% in our cohort) in 30-40% of cases in the most experienced centres." - Anonymous Online Contributor

Unverified Answer

How serious can parathyroid diseases be?

"Hyper and hypocalcemia can have a serious effect on patients and it is the major reason of the admission to the Internal Medicine Service in the Internal Medicine Department of Universidad Autónoma de Santander." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for parathyroid diseases?

"Physicians and scientists should seriously consider trial for high-risk PTH-related bone demineralization disease for those with high PTH levels, or high risk PTH-related skeletal loss for those who have high Ca x P product." - Anonymous Online Contributor

Unverified Answer

What causes parathyroid diseases?

"Parathyroid diseases are most commonly caused by an increase in serum calcium, due to hyperparathyroidism or vitamin D deficiency. If parathyroid hyperplasia or adenomas are present, disease must be detected before surgery. When adenomas are detected, surgery often has good long-term results." - Anonymous Online Contributor

Unverified Answer

What is parathyroid diseases?

"There is a vast number of parathyroid-related disease with all types of abnormal hormone-producing parathyroid tissue and is a leading reason for the cause for low calcium levels and hypoparathyroidism. An exhaustive, detailed history with regards to physical, laboratory, radiological investigations and all other problems/interventions as well as the use of medication will aid in diagnosis and treatment." - Anonymous Online Contributor

Unverified Answer

What are common treatments for parathyroid diseases?

"Based on this review, there were many new treatments, such as radioactive iodine, scanning, PET imaging, and magnetic resonance imaging (MRI) in this discipline, but also the use of certain conventional treatments." - Anonymous Online Contributor

Unverified Answer

What are the signs of parathyroid diseases?

"Symptoms may appear in the early phase of the disease. The primary complaint includes headache, and other systemic manifestations may depend on the sites of involvement." - Anonymous Online Contributor

Unverified Answer

How many people get parathyroid diseases a year in the United States?

"Approximately 3% to 4% of people are diagnosed with primary hyperparathyroidism, approximately 1% to 1.5% with secondary hyperparathyroidism, and approximately 13% of people develop persistent or chronic osteitis fibrosa. While there were no significant differences in parathyroid disease prevalence between men and women, women had significantly more severe disease." - Anonymous Online Contributor

Unverified Answer

What is the latest research for parathyroid diseases?

"Due to the high prevalence, parathyroid biopsy remains a diagnostic tool of choice for patients with chronic kidney disease. The increased use of parathyroid biopsy in older patients with kidney disease suggest that our knowledge and understanding of the pathological process, such as micro-involvement, has gained more confidence. The number of patients with parathyroid carcinoma and hypoparathyroidism is increasing." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of pteye?

"This is the first study reporting the prevalence of pteye. Results from a recent paper indicate a higher prevalence in women than men. The common side effects reported include nausea, vomiting, diarrhea, itching, chest pain, and tachycardia but were not specific to women." - Anonymous Online Contributor

Unverified Answer

Is pteye typically used in combination with any other treatments?

"The percentage of patients who received PT alone was 7.3% but doubled to 14.8% when PT was used in combination with the other drugs. A combination of PT and ATC was most common in the elderly." - Anonymous Online Contributor

Unverified Answer

Has pteye proven to be more effective than a placebo?

"The drug is well tolerated with an insignificant increase in haemorrhage in this small pilot study. However, it is important that larger studies are conducted to ascertain if PTE is an effective alternative to a placebo in the treatment of primary hyperparathyroidism." - 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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