Applications

Why remove the thyroid gland in order
to eliminate the symptoms of benign nodules?

ModìLite is the ECHOLASER Therapy for treating neck lesions, namely benign thyroid nodules.

The name of the treatment contains in a single word the application area (the neck, “Modì” was the nickname of Tuscan painter, Amedeo Modigliani, who portrayed female subjects with very long, slim necks) and “Lite”, which on one hand refers to the lightweight and micro-invasiveness of the treatment, and on the other, the therapeutic source (Light, therefore Laser).

The name ModìLite marks the difference of the procedure performed with ECHOLASER (micro-invasiveness and multi-fibre approach in a single system) from the other thermal ablation techniques.

Suitability

ModìLite is indicated for those who have one or more benign solid thyroid nodules which are large enough to create aesthetic damage or local compression symptoms, or for those who prefer not to undergo surgery. ModìLite is also a safe and effective treatment for subjects who, due to critical medical conditions, are not able to undergo surgery.
Despite focusing on treatment of benign solid thyroid nodules, Modìlite is also effective for malignant neck lesions such as metastatic lymph nodes. With this application, the treatment is radical, resulting in a complete ablation of the lesion.

 

Performance

  • Reduction in volume of benign thyroid nodules due to the Laser Induced CytoReduction (LICR) process, resulting in an improbvement of local symptoms;
  • Complete ablation of malignant neck tumours, with a sufficient safety margin

What is it?

Modìlite consists of the percutaneous insertion of optical fibres (1 or 2 depending on the size of the nodule), and the delivery of laser energy for several minutes, which heats the tissues until they are destroyed. Subsequently, the progressive reduction of the volume of the thyroid nodule (reduction of at least > 50% compared to the basal volume at the one-year follow-up) induced by the natural reduction mechanisms of the necrotic tissues of the human body leads to the disappearance of the compressive symptoms and aesthetic damage to the neck. The planning of the treatment, the insertion of the needles and the monitoring are all carried out under ultrasound guidance. In order to facilitate the insertion manoeuvre and plan the best positioning of the needles in the lesion, ECHOLASER employs:

  • dedicated multi-applicator Guiding Systems for ultrasound probes specifically designed for the anatomical area of the thyroid, with the relative Biopsy Software that displays the guidelines on the screen;
  • Planning Software in the ultrasound unit that allows physicians to choose among the various treatment possibilities, the most suitable and safest for each specific case, and verify the correct positioning of the needles inside the nodule.

A single ModìLite treatment leads to a significant and persistent reduction in the volume of the thyroid nodule and improves local symptoms without any changes to the thyroid function.

Clockwise:
1./2. LA332 Esaote probe with dedicated multi-fibre Guiding System
3. Biopsy Software related to multi-fibre Guiding System / 4.Planning Software

Advantages

  • a reduction of the compressive symptoms and/or aesthetic damage
  • “in situ” thermal destruction with a consequent reduction of the nodule volume
  • preservation of the healthy tissue and the organ function
  • highly predictable and repeatable coagulation volume, as required in the small organs
  • use of fine, non-traumatic needles for neck structures
  • option of treating patients with pace-makers (excellent electromagnetic compatibility)
  • no general anaesthesia (thanks to the very fine needles not even local anaesthetic is necessary)
  • short duration of the treatment (few minutes)
  • no scars on the neck
  • rapid recovery
  • life-long hormone replacement therapy not necessary
  • no or insignificant post-treatment pain

For more details about the ModìLite procedure, EchoLaser Therapy on benign thyroid nodules, please go to the dedicated website: www.modilite.info

 

 

 

 

Clinical Case no.1

Benign Thyroid Nodule

A patient with a solid isoechoic nodule (volume 20ml) in the right thyroid lobe, underwent EchoLaser Therapy. No discomfort was reported by the patient during the treatment .

CEUS image after the treatment showing the hypoechoic zone of the coagulation area

 

The ultrasound scan at the two-year follow-up showed a reduction in the nodule volume equal to 70% compared to the basal volume.

US images before the treatment and at the two-year follow-up showing the reduction of the nodule

Images courtesy of Dr. Rago (Cisanello Hospital, Pisa)

Clinical Case no.2

Metastatic Lymph nodes in the neck

Patient with metastatic lymph node from papillary thyroid carcinoma has been treated with the EchoLaser Therapy with two fibres.

CEUS image showing the high absorption of the contrast of the pathological lymph node

US image showing two fibres inside the lymph node

 

CEUS image showing the absence of enhancement after the treatment

 

Images courtesy of Dr. Giovanni Mauri (IEO Hospital, Milan)

 

 

 

Benign Thyroid Nodules

Quality of life and outcomes in patients with a large toxic adenoma undergoing laser ablation plus radioiodine vs lobectomy.
Negro R, Greco G.
Int J Hyperthermia. 2018 Dec 16:1-5.

Benign thyroid nodule unresponsive to radiofrequency ablation treated with laser ablation: a case report.
Oddo S, Balestra M, Vera L, Giusti M.
J Med Case Rep. 2018 May 11;12(1):127.

Percutaneous Ethanol Injection in Combination with Laser Ablation for a 100 ml Partially Cystic Thyroid Nodule.
Negro R, Greco G.
Case Rep Endocrinol. 2018 Feb 15;2018:8046378.

A single session of laser ablation for toxic thyroid nodules: three-year follow-up results.
Gambelunghe G, Stefanetti E, Colella R, Monacelli M, Avenia N, De Feo P.
Int J Hyperthermia. 2018 Feb 22:1-5.

Quality of Life in Patients Treated with Percutaneous Laser Ablation for Non-Functioning Benign Thyroid Nodules: A Prospective Single-Center Study
Oddo S, Felix E, Mussap M, Giusti M.
Korean J Radiol 2018;19(1):175-184

Image-guided thermal ablation of benign thyroid nodules.
Pacella CM.
J Ultrasound. 2017 Nov 14;20(4):347-349.

A comparison of laser with radiofrequency ablation for the treatment of benign thyroid nodules: a propensity score matching analysis.
Pacella CM et al
Int J Hyperthermia. 2017 Jun 12:1-9.

Percutaneous laser ablation for benign thyroid nodules: a meta-analysis.
Sui WF, Li JY, Fu JH.
Oncotarget. 2017 May 17.

Laser ablation is more effective for spongiform than solid thyroid nodules. A 4-year retrospective follow-up study.
Negro R, Salemb TM and Greco G.
Int J Hyperthermia. 2016 Nov;32(7):822-8.

Benign thyroid nodules treatment using percutaneous laser ablation (PLA) and radiofrequency ablation (RFA).
Mauri G, Cova L, Monaco CG, Sconfienza LM, Corbetta S, Benedini S, Ambrogi F, Milani V, Baroli A, Ierace T& Solbiati L
Int J Hyperthermia. 2016 Nov 15:1-5.

Detection of the Single-Session Complete Ablation Rate by Contrast-Enhanced Ultrasound during Ultrasound-Guided Laser Ablation for Benign Thyroid Nodules: A Prospective Study
Shuhua Ma, Ping Zhou, XiaominWu, Shuangming Tian, and Yongfeng Zhao
BioMed Research International Volume 2016 (2016), Article ID 9565364, 8 pages

AACE/ACE/AME Thyroid Nodule Management Guidelines
Gharib H, Papini E, Garber JR, Duick DS, Harrel RM, Hegedüs L, Paschke R, Valcavi R, Vitti P
Endocr Pract. 2016;22 (Suppl 1)

Thyroid: Laser ablation of thyroid nodules is rapid, safe and effective
Geach T.
Nat Rev Endocrinol. 2015 Nov;11(11):631.

Outcomes and Risk Factors for Complications of Laser Ablation for Thyroid Nodules. A Multicenter Study on 1531 Patients.
Pacella CM, Mauri G, Achille G, Barbaro D, Bizzarri G, De Feo P, Di Stasio E, Esposito R, Gambelunghe G, Misischi I, Raggiunti B, Rago T, Patelli GL, D’Este S, Vitti P, Papini E.
J Clin Endocrinol Metab. 2015 Oct;100(10):3903-10.

Ultrasound-guided percutaneous laser ablation (LA) in treating symptomatic solid benign thyroid nodules: Our experience in 45 patients.
Achille G, Zizzi S, Di Stasio E, Grammatica A, Grammatica L.
Head Neck. 2014 Dec 18.

Thyroid nodule morphology affects the efficacy of ultrasound-guided interstitial laser ablation: A nested case-control study.
Gambelunghe G, Bini V, Stefanetti E, Colella R, Monacelli M, Avenia N, De Feo P.
Int J Hyperthermia. 2014 Oct 7:1-4

Long-term Efficacy of Ultrasound-Guided Laser Ablation for Benign Solid Thyroid Nodules. Results of a Three-Year Multicenter Prospective Randomized Trial.
Papini E, Rago T, Gambelunghe G, Valcavi R, Bizzarri G, Vitti P, De Feo P, Riganti F, Misischi I, Di Stasio E, Pacella CM.
J Clin Endocrinol Metab. 2014 Oct;99(10)

Laser ablation and 131-iodine: a 24-month pilot study of combined treatment for large toxic nodular goiter.
Chianelli M, Bizzarri G, Todino V, Misischi I, Bianchini A, Graziano F, Guglielmi R, Pacella CM, Gharib H, Papini E.
J Clin Endocrinol Metab. 2014 Jul;99(7)

Diagnosis of endocrine disease: thyroid ultrasound (US) and US-assisted procedures: from the shadows into an array of applications.
Papini E, Pacella CM, Hegedus L.
Eur J Endocrinol. 2014 Mar 14;170(4):R133-46

Clinical review: Nonsurgical, image-guided, minimally invasive therapy for thyroid nodules.
Gharib H, Hegedüs L, Pacella CM, Baek JH, Papini E
J Clin Endocrinol Metab. 2013 Oct;98(10):3949-57.

Image-guided percutaneous ablation therapies for local recurrences of thyroid nodule.
Pacella CM and Papini E
J.Endocrinol.Invest.36: 61-70;2013

The administration of anesthetic in the thyroid pericapsular region increases the possibility of side effects during percutaneous laser photocoagulation of thyroid nodules.
Gambelunghe G, Bini V, Monacelli M, Avenia N, D’Ajello M, Colella R, De Feo P
Lasers Surg Med. 2013

Ultrasound-Guided Interstitial Laser Ablation for Thyroid Nodules Is Effective Only at High Total Amounts of Energy: Results From a Three-Year Pilot Study.
Gambelunghe G, Fede R, Bini V, Monacelli M, Avenia N, D’Ajello M, Colella R, Nasini G, De Feo P
Surg Innov. 2012

Percutaneous Laser Ablation of Cold Benign Thyroid Nodules: A 3-Year Follow-Up Study in 122 Patients.
Valcavi R,Riganti F,Bertani A,Formisano D, Pacella CM
Thyroid 2010; Volume 20, Number 11

Laser and Radiofrequency Ablation procedures.
Valcavi R, Bertani A, Pesenti , Al Jandali, Frasoldati, Formisano, Pacella CM.
Thyroid Ultrasound and Ultrasound-Guided FNA
Springer

Treatment of Benign Cold Thyroid Nodules: A Randomized Clinical Trial of Percutaneous Laser Ablation Versus Levothyroxine Therapy or Follow-up
Papini E, Guglielmi R, Bizzarri G, Graziano F, Bianchini A, Brufani C, Pacella S, Valle D, Pacella CM.
Thyroid. 2007 Mar;17(3):229-35.

Thyroid Tissue: US-guided Percutaneous Interstitial Laser Ablation—A Feasibility Study.
Pacella CM, Bizzarri G, Guglielmi R, Anelli V, Bianchini A, Crescenzi A, Pacella S, Papini E.
Radiology. 2000 Dec;217(3):673-7

Metastatic Lymph Node in the neck

Percutaneous ultrasound-guided laser ablation for the treatment of cervical tuberculous lymphadenitis: a pilot study.
Yang G, Fang J, Yu T, Zhang Y, Zhang W, Zhao D, Xu J, Wang C.
J Int Med Res. 2019 Jan 11:300060518821818.

Ultrasound-guided laser ablation for local control of neck recurrences of medullary thyroid cancer. A feasibility study.
Persichetti A, Bizzarri G, Guglielmi R, Barnabei A, Bianchini A, Coccaro C, Appetecchia M, Papini E.
Int J Hyperthermia. 2018 Sep 11:1-5.
Role of ultrasound in the assessment of percutaneous laser ablation of cervical metastatic lymph nodes from thyroid carcinoma.
Zhang L, Zhou W, Zhan W.
Acta Radiol. 2017 Jan 1:284185117721261.

Percutaneous laser ablation for treatment of locally recurrent papillary thyroid carcinoma <15 mm
Zhou W, Zhang L, Zhan W, Jiang S, Zhu Y, Xu S.
Clin Radiol 2016 Dec;71(12):1233-1239.

Treatment of Metastatic Lymph Nodes in the Neck from Papillary Thyroid Carcinoma with Percutaneous Laser Ablation.
Mauri G, Cova L, Ierace T, Baroli A, Di Mauro E, Pacella CM, Goldberg SN, Solbiati L
Cardiovasc Intervent Radiol. 2016 Jul;39(7):1023-30

Percutaneous Laser Ablation of Metastatic Lymph Nodes in the Neck from Papillary thyroid carcinoma: preliminary results.
Mauri G, Cova L, Tondolo T, Ierace T, Baroli A, Di Mauro E, Pacella CM, Goldberg SN, Solbiati L
J Clin Endocrinol Metab. 2013 May 10.

Percutaneous ultrasound-guided laser ablation is effective for treating selected nodal metastases in papillary thyroid cancer.
Papini E, Bizzarri G, Bianchini A, Valle D, Misischi I, Guglielmi R, Salvatori M, Solbiati L, Crescenzi A, Pacella CM, Gharib H.
J Clin Endocrin Metab, 2013 Jan;98(1):E92-7

 

 

 

 

 

 

 

 

The videos on the page are commented by the respective healthcare professionals, EchoLaser Therapy experts on thyroid nodules.

Professor Bruno Raggiunti
Endocrinology Department Director, San Liberatore Hospital (Atri) – Italy

 

Teresa Rago, MD
Head physician of the Endocrinology Department, Cisanello Hospital (Pisa) – Italy

 

 

 

 

 

 

 

Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results

Multicentre Randomized Clinical Trial
No. of patients enrolled: 200
Reference Centres of the study: 4, Azienda Ospedaliero-Universitaria di Pisa – Presidio di Cisanello, Ospedale Regina Apostolorum, Azienda Ospedaliera di Perugia, Arcispedale Santa Maria Nuova
Study status: Completed
Registered on ClinicalTrial.gov: https://clinicaltrials.gov/ct2/show/NCT00858104
Publications of the results: Long-term Efficacy of Ultrasound-Guided Laser Ablation for Benign Solid Thyroid Nodules. Results of a Three-Year Multicenter Prospective Randomized Trial, Papini E, Rago T, Gambelunghe G, Valcavi R, Bizzarri G, Vitti P, De Feo P, Riganti F, Misischi I, Di Stasio E, Pacella CM. J Clin Endocrinol Metab. 2014 Oct

Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules (LARA)

Randomised Clinical Trial
No. of patients enrolled: 60
Reference Study Centre: Ospedale, Santa Maria Goretti, Latina
Study status: patients enrolment
Registered on ClinicalTrial.gov: https://clinicaltrials.gov/ct2/show/NCT02714946?term=laser+versus+radiofrequency+thyroid&rank=1

 

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