Primary Hyperparathyroidism Due to AdenomaNIRAF MIVAPNCT06779760
Near Infrared Autofluorescence Imaging in Minimally-Invasive Video-Assisted Parathyroidectomy (NIRAF MIVAP Study)
An observational study of Primary Hyperparathyroidism Due to Adenoma, run by Aristotle University Of Thessaloniki at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism Due to Adenoma
- What is being tested?
- parathyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteJordan
- Study dates
- 20 Sep 2024to 20 Oct 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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: patients with parathyroid adenoma undergoing surgery and age >18 years old
Who may be able to join
- patients diagnosed with parathyroid adenoma undergoing surgery
Who cannot join
- patients <18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Feasibility of Near Infrared Autofluorescence Imaging in Minimally-Invasive Video-Assisted Parathyroidectomy and the Autofluorescence Signature of Parathyroid Adenomas
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
- Being tested
- parathyroidectomy
- Keywords
- primary hyperparathyroidism, parathyroid adenoma, near-infrared autofluorescence, minimally invasive parathyroidectomy
- Medical subject headings
- Parathyroid Neoplasms, Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parathyroidectomyProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
patterns of autofluorescence in parathyroid adenomas
Measured: during surgery
Secondary outcomes (3)
specific autofluorescence patterns correlated with the dominant cell type of a parathyroid adenoma
Measured: during surgery
specific autofluorescence patterns correlated with adenoma size
Measured: during surgery
specific autofluorescence patterns correlated with adenoma location
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start20 Sep 2024
- Primary completion15 Oct 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Hyperparathyroidism Due to AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 24 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- The Hashemite University
- Responsible party
- Principal investigator, Papavramidis Theodossis, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779760
- Sponsor's protocol ID
- NIRAF MIVAP study
- Acronym
- NIRAF MIVAP
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bakkar S, Chorti A, Papavramidis T, Donatini G, Miccoli P. Assessing the feasibility of near infrared autofluorescence imaging in minimally-invasive video assisted parathyroidectomy and the autofluorescence signature of parathyroid adenomas. A single center surgical case series. Surg Endosc. 2025 May;39(5):2964-2972. doi: 10.1007/s00464-025-11675-8. Epub 2025 Mar 21.
PubMed 40119064
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Near Infrared Autofluorescence Imaging in Minimally-Invasive Video-Assisted Parathyroidectomy and the Autofluorescence Signature of Parathyroid Adenomas
- ClinicalTrials.gov ID
- NCT06779760
- Acronym / sponsor ID
- NIRAF MIVAP / NIRAF MIVAP study
- Keywords
- primary hyperparathyroidism, parathyroid adenoma, near-infrared autofluorescence, minimally invasive parathyroidectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- The Hashemite University
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with parathyroid adenoma undergoing surgery and age >18 years old
Key inclusion criteria (1 listed)
- patients diagnosed with parathyroid adenoma undergoing surgery
Key exclusion criteria (1 listed)
- patients <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parathyroidectomyThe 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 | Procedure or surgery | – |
Primary outcome
patterns of autofluorescence in parathyroid adenomas
Time frame: during surgery
3 secondary outcomes
specific autofluorescence patterns correlated with the dominant cell type of a parathyroid adenoma
Time frame: during surgery
specific autofluorescence patterns correlated with adenoma size
Time frame: during surgery
specific autofluorescence patterns correlated with adenoma location
Time frame: during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 40119064Bakkar S, Chorti A, Papavramidis T, Donatini G, Miccoli P. Assessing the feasibility of near infrared autofluorescence imaging in minimally-invasive video assisted parathyroidectomy and the autofluorescence signature of parathyroid adenomas. A single center surgical case series. Surg Endosc. 2025 May;39(5):2964-2972. doi: 10.1007/s00464-025-11675-8. Epub 2025 Mar 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism Due to Adenoma, run by Aristotle University Of Thessaloniki at 1 site in Jordan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jan 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patterns of autofluorescence in parathyroid adenomas (time frame: during surgery). 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 NCT06779760, 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 17 Jan 2025.