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Thyroid NeoplasmsPTFinderNCT07010380

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

An observational study of Thyroid Neoplasms and Hyperparathyroidism, run by Bo Wang,MD at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PTFinder Dual-Channel NIR Autofluorescence Imaging System and Offline Machine-Learning Algorithm (PTFinder-AI Beta)
Type of treatment
Medical device
How many people
180 participants
Where
1 siteChina
Study dates
1 Jun 2025to 31 Dec 2029
How long will I take part?
7 Days
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bo Wang Professor, MD contact

+86 13959123550

wangbo@fjmu.edu.cn

China1 site, 1 recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, FJ, 350001

    Bo Wang Professor, MD, +86 13959123550, wangbo@fjmu.edu.cn

    Bo Wang, MD

    Recruiting

Other trials in China

About this study

Official title: A Multicenter Prospective Paired Observational Study Evaluating the Performance of the PTFinder Dual-Channel Near-Infrared and White-Light Imaging System With AI-Assisted Analysis for Rapid Identification of Parathyroid Glands in Surgical Specimens

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.

Read the detailed description

Prospective, paired, observational study at three endocrine-surgery centers. For each specimen:

PTFinder scan - stopwatch runs until the first gland is seen; all suspected glands are marked.

White-light exam - second investigator, blinded to device results, inspects the same specimen.

All marked tissue plus a random "negative" sample go to frozen section or rapid PTH strip; discrepancies are settled by permanent histology.

Outcomes

Primary - time to first gland; detection rate per specimen.

Secondary - sensitivity, specificity, PPV, NPV; post-operative PTH and calcium at 1 h, 24 h, 7 d; incidence of hypocalcaemia.

Sample size: 60 specimens per site (total = 180) gives 80 % power to detect a rise in detection rate from 70 % to 90 % (α = 0.05, McNemar).

Analysis: Paired tests for efficiency, mixed-effects models for accuracy and lab values; multiple imputation for missing data.

Safety \& Oversight: PTFinder emits low-intensity NIR light only on ex-vivo tissue; no patient exposure. Device is investigational, not under an FDA IDE. Ethics approval obtained from Fujian Medical University Union Hospital IRB (FJMU-IRB-2025-PTF); other sites use the same central IRB agreement. Data are stored in a secure eCRF.

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.

Being tested
PTFinder Dual-Channel NIR Autofluorescence Imaging System, Offline Machine-Learning Algorithm (PTFinder-AI Beta)
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
Medical subject headings
Thyroid Neoplasms, Hyperparathyroidism, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PTFinder Dual-Channel NIR Autofluorescence Imaging SystemDevice

    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).

  • Offline Machine-Learning Algorithm (PTFinder-AI Beta)Other

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

Study groups in NCT07010380
Study groupRoleWhat they receive
Surgical Specimen CohortAdults (≥18 y) undergoing thyroid or parathyroid surgery; their excised specimens will be imaged ex vivo with the PTFinder device for parathyroid-gland identification.
Receives: Device: PTFinder Dual-Channel NIR Autofluorescence Imaging System; Other: Offline Machine-Learning Algorithm (PTFinder-AI Beta)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Intra-operative imaging session (0-5 minutes)

Secondary outcomes (6)

  1. Time to First Parathyroid Gland Identification (PTFinder)

    Seconds from start of device scanning to first verified gland highlight (stopwatch). Lower value indicates faster localisation.

    Measured: 1 day (Same imaging session)

  2. Sensitivity of PTFinder

    True-positive glands / (true-positive + false-negative) versus frozen pathology/PTH strip. Unit = %.

    Measured: 1 day (Same imaging session)

  3. Specificity of PTFinder

    True-negative sites / (true-negative + false-positive). Unit = %.

    Measured: 1 day (Same imaging session)

  4. Serum PTH Level

    Mean parathyroid hormone concentration (pg/mL) at each time-point.

    Measured: 1 hour , 24 hours, 7 days post-op

  5. Corrected Serum Calcium Level

    Mean calcium (mmol/L) adjusted for albumin.

    Measured: 1 hour , 24 hours, 7 days post-op

  6. Incidence of Hypocalcaemia

    % of participants with corrected calcium <2.0 mmol/L or symptoms requiring supplementation.

    Measured: Up to 7 days post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2025
  2. Study start1 Jun 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
180 participants (estimated)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07010380
Sponsor's protocol ID
PTFinder 3 Dual
Acronym
PTFinder
Status last verified
Jun 2025
First submitted
1 Jun 2025
Last updated
18 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified individual-level data-NIR/RGB image files, time-to-detection, pathology confirmation, and postoperative PTH \& calcium values-will be available 6 months after the primary manuscript is published, for 3 years, to qualified researchers who provide a methodologically sound proposal and sign a data-use agreement. Requests should be sent to the Principal Investigator (wangbo@fjmu.edu.cn).

Publications

  • 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.

    PubMed 39034960

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Neoplasms and Hyperparathyroidism, run by Bo Wang,MD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bo Wang Professor, MD (+86 13959123550, wangbo@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection Rate of Pathology-Confirmed Parathyroid Glands per Specimen (PTFinder) (time frame: Intra-operative imaging session (0-5 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07010380, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.

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