Dual-Channel Near-Infrared Autofluorescence Imaging and AI Analysis to Locate Parathyroid Glands (PTFinder)

NCT07010380 | Recruiting FDA Device

• 1 other identifier: PTFinder 3 Dual
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests PTFinder, a dual-camera system that makes parathyroid glands glow on screen by capturing their natural near-infrared autofluorescence. After a thyroid or parathyroid operation, the removed tissue is scanned with PTFinder and then checked again under normal white light. We will measure how fast (seconds) and how accurately the device finds real glands, confirmed by frozen pathology or a rapid PTH strip. About 180 adult patients at three Chinese hospitals will join. The imaging adds only a few minutes and does not change any part of the surgery. We will also record blood calcium and PTH at 1 h, 24 h, and 7 d after surgery to see whether better gland recovery lowers low-calcium risk.Collected images will also be used to train and test a deep-learning model for fully automated parathyroid recognition; model performance metrics constitute secondary outcomes.

Conditions

Thyroid Neoplasms; Hyperparathyroidism; Parathyroid Gland

Keywords

Near-Infrared Autofluorescence (NIRAF); Parathyroid Identification; PTFinder Device; Dual-Channel Imaging; Rapid PTH Test Strip; Thyroidectomy Specimen; Ex-Vivo Fluorescence Camera; Sensitivity and Specificity; Artificial Intelligence; Deep Learning; Computer Vision; NIRAF 3 Dual; PTFinder 3 Dual; PTFinder 3.0 Dual; NIRAF 3.0 Dual

Outcome Measures

Primary Outcomes (1)

• Detection Rate of Pathology-Confirmed Parathyroid Glands per Specimen (PTFinder)

  Proportion of parathyroid glands correctly located by PTFinder divided by the total number of glands confirmed on frozen section or rapid PTH strip. Unit = % (higher = better).

  Intra-operative imaging session (0-5 minutes)

Secondary Outcomes (6)

• Time to First Parathyroid Gland Identification (PTFinder)

  1 day (Same imaging session)

• Sensitivity of PTFinder

  1 day (Same imaging session)

• Specificity of PTFinder

  1 day (Same imaging session)

• Serum PTH Level

  1 hour , 24 hours, 7 days post-op

• Corrected Serum Calcium Level

  1 hour , 24 hours, 7 days post-op

Study Arms (1)

Surgical Specimen Cohort

Adults (≥18 y) undergoing thyroid or parathyroid surgery; their excised specimens will be imaged ex vivo with the PTFinder device for parathyroid-gland identification.

Device: PTFinder Dual-Channel NIR Autofluorescence Imaging System; Other: Offline Machine-Learning Algorithm (PTFinder-AI Beta)

Interventions

PTFinder Dual-Channel NIR Autofluorescence Imaging System DEVICE

Ex vivo, non-contact imaging of resected thyroid/parathyroid specimens; captures near-infrared autofluorescence and overlays it on white-light video to highlight parathyroid glands (2-5 min per specimen).

Surgical Specimen Cohort

Offline Machine-Learning Algorithm (PTFinder-AI Beta) OTHER

training/validation on de-identified NIR/RGB frames.

Surgical Specimen Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive adult patients undergoing thyroid or parathyroid surgery at three tertiary endocrine-surgery centers in China (Fuzhou, Xiamen, and Wenzhou). Approximately 60 participants will be enrolled per center, for a planned total of 180 surgical specimens. The cohort reflects routine clinical practice and is intended to evaluate the ex-vivo performance of the PTFinder near-infrared autofluorescence imaging device.

You may qualify if:

• Age ≥18 years.
• Scheduled for elective total thyroidectomy, hemithyroidectomy, or parathyroidectomy with removal of thyroid/parathyroid tissue.
• Able and willing to provide written informed consent for participation and specimen imaging.

You may not qualify if:

• History of neck irradiation or prior neck surgery that may distort parathyroid anatomy.
• Pregnancy or breastfeeding.
• Confirmed or suspected parathyroid carcinoma, or thyroid carcinoma requiring en-bloc parathyroid resection.
• Inability to understand the study procedures or to comply with follow-up.

Sponsors & Collaborators

• Bo Wang,MD: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, FJ, 350001, China

RECRUITING

Related Publications (1)

• Wang B, Zhou CP, Ao W, Cai SJ, Ge ZW, Wang J, Huang WY, Yu JF, Wu SB, Yan SY, Zhang LY, Wang SS, Wang ZH, Hua S, Abdelhamid Ahmed AH, Randolph GW, Zhao WX. Exploring near-infrared autofluorescence properties in parathyroid tissue: an analysis of fresh and paraffin-embedded thyroidectomy specimens. J Biomed Opt. 2025 Jan;30(Suppl 1):S13702. doi: 10.1117/1.JBO.30.S1.S13702. Epub 2024 Jul 18.

  PMID: 39034960 BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms; Hyperparathyroidism; Hypersensitivity

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Parathyroid Diseases; Immune System Diseases

Central Study Contacts

Bo Wang Professor, MD

CONTACT

+86 13959123550; wangbo@fjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 8, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: "De-identified image dataset and trained AI weights will be deposited in an open repository (e.g., Zenodo) 6 months after publication, pending IRB approval."
• Access Criteria: Researchers must obtain IRB approval or exemption and agree to use the data only for scientific purposes.

Locations

CN (1)