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CompletedNCT06779760NIRAF MIVAPUpdated Jan 17, 2025

Near Infrared Autofluorescence Imaging in Minimally-Invasive Video-Assisted Parathyroidectomy (NIRAF MIVAP Study)

An observational study in Primary Hyperparathyroidism Due to Adenoma, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Aristotle University Of Thessaloniki · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
18 Years and older
Sex
All
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Study summary

The role of near-infrared autofluorescence (NIRAF)-imaging as an adjunct in thyroid surgery is well established. However, its diagnostic role in hyperparathyroidism surgery is yet to be defined due to the lack of consensus regarding the autofluorescence (AF) pattern of pathological parathyroid glands. Furthermore, its utility via a direct minimal access has not been assessed.

To assess the AF pattern of parathyroid adenomas (PAs) utilizing NIRAF-imaging in minimally invasive video-assisted parathyroidectomy (MIVAP).

The clinical records of patients who underwent MIVAP for hyperparathyroidism between February and October 2024 were retrospectively reviewed. The primary endpoint was to assess the AF pattern of PAs. Secondary endpoints included the feasibility of applying NIRAF imaging in MIVAP and whether certain AF patterns of PAs correlated with cell type, size, and/or location. Furthermore, operative-time and cost implications were assessed.

Read the detailed description

Native fluorescence or autofluorescence (AF) is defined as the emission of light by a naturally occurring fluorophore, on excitation by incident light of a specific wavelength. Accordingly, fluorescence produced by an endogenous fluorophore differs from that resulting from the application of a synthetic fluorescent marker and is, therefore, considered "contrast-free fluorescence." Maximal AF from both thyroid and parathyroid tissue occurs at the near-infrared spectrum (820-830 nm wavelength) with parathyroid tissue maximal emission intensity being 2-20 times greater than that of thyroid tissue and lasts at least for one hour in vivo. This is probably attributed to that the fluorophore assumed to be responsible for thyroid and parathyroid tissue AF is the calcium-sensing receptor that is present in parafollicular cells (C-cells), but to a much higher extent in parathyroid tissue. This allows for PTGs to be visualized as bright spots on a background of low fluorescence (thyroid gland). The fact that AF persists for at least an hour even after gland devascularization or unintentional resection, implies that NIRAF cannot confirm PTG viability. Viability depends on adequate tissue perfusion. This in turn requires assessing tissue vascularity using AF from a synthetic fluorescent marker such as indocyanine green (ICG); the concept of contrast-enhanced AF rather than contrast-free AF.

The property of AF in a tissue depends on the concentration of the endogenous fluorophore and whether it is affected by a pathological process. Hence, its application in clinical practice allowing it to serve as an optical biopsy (a point detection tool that provides real-time, non-invasive diagnostic information without physically exciting tissue). This might explain why unlike normal parathyroid tissue, parathyroid adenomas (PAs) demonstrate a heterogenous pattern of AF. Demarchi et al. reported that most PAs in their study appeared significantly less autofluorescent than the rim of compressed normal parathyroid tissue (at the periphery of a PA) that appeared as bright cap. This was referred to as cap AF. Nevertheless, no noticeable differences in the pattern of AF between adenomatous, hyperplastic, and normal PTGs were observed by others.

Minimally invasive video-assisted parathyroidectomy (MIVAP) is one of the most popular targeted parathyroid procedures performed for primary hyperparathyroidism. It has been demonstrated that the advantages offered by MIVAP enables it to overcome the limitations of other targeted parathyroid procedures. Allowing for full neck exploration and/or performing a concomitant thyroid procedure without the need to convert to a standard cervicotomy.

The objective of this study was to assess the feasibility of applying NIRAF-imaging via a limited direct access and the potential patterns of AF (AF signature) of PAs on contrast-free NIRAF-based imaging, and whether specific patterns of AF correlated with factors intrinsic to PAs such as the dominant cell type of a PA, its size and/or location. The additional operative time, and cost conferred using this technology were also evaluated

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Conditions studied

  • Primary Hyperparathyroidism Due to Adenoma

Keywords

  • primary hyperparathyroidism
  • parathyroid adenoma
  • near-infrared autofluorescence
  • minimally invasive parathyroidectomy
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In context

Parathyroid Neoplasms

63 studies on the registry are indexed under Parathyroid Neoplasms; 19 are open to participants now.

This study's enrollment of 24 is below the median of 100 across 20 observational studies indexed under Parathyroid Neoplasms.

Browse Parathyroid Neoplasms studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 282 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with parathyroid adenoma undergoing surgery and age >18 years old

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients diagnosed with parathyroid adenoma undergoing surgery

Exclusion criteria

Exclusion Criteria:

  • patients \<18 years old
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • Procedureparathyroidectomy

    The FLUOBEAM® LX apparatus consists of a camera with a built-in light emitter (750-800 nm) and detector (800-830 nm) connected to a processor with an indication-oriented software (Fluosoft®). The processor captures the emitted light, allowing display of PTG images in real time. The camera is placed in a sterile sheath and is held perpendicularly at 8 cm from the target tissue with operating lights, all background lights, and any ambient light being extinguished. The reported depth of tissue penetration of near-infrared light is limited to a maximum of 3 mm only with no observed differences between superior and inferior PTGs \[10\]. This highlights the importance of a major surgical technical point "reaching the correct plane of dissection" namely, the pre-vertebral fascia to maximize the chances of eliciting an adequate signal from parathyroid tissue. The correct application of the technology has demonstrated a success rate of signal elicitation of 90%-100% \[11\]. The ability of near-infr

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What researchers measure

Primary outcomes

  1. patterns of autofluorescence in parathyroid adenomas

    Time frame: during surgery

Secondary outcomes

  1. specific autofluorescence patterns correlated with the dominant cell type of a parathyroid adenoma

    Time frame: during surgery

  2. specific autofluorescence patterns correlated with adenoma size

    Time frame: during surgery

  3. specific autofluorescence patterns correlated with adenoma location

    Time frame: during surgery

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Study locations

1 site
  • the Hashemite Univesity
    Zarqa, Jordan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2024 to primary completion in Oct 2024, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2024
First posted
Jan 17, 2025
StartActual
Sep 20, 2024
Primary completionActual
Oct 15, 2024
CompletionActual
Oct 20, 2024
Last update
Jan 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06779760
Collaborators
The Hashemite University
Responsible party
Papavramidis Theodossis (Professor of Surgery, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Jan 17, 2025
Start date
Sep 20, 2024
Primary completion
Oct 15, 2024
Completion
Oct 20, 2024
Last update
Jan 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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