Thyroid Nodule
Conditions
Keywords
Benign thyroid nodule
Brief summary
This is a prospective trial to evaluate the effects of laser ablation on symptomatic benign thyroid nodules. The study is designed to assess the clinical efficacy, safety, tolerability and impact on symptoms of single ultrasound guided laser ablation treatment of symptomatic benign thyroid nodules. Approximately 20 subjects will undergo laser ablation of symptomatic benign nodules.
Detailed description
* Laser ablation will be carried out in a single session under sterile conditions and ultrasound guidance with the support of Echolaser Smart Interface. * Local anesthesia will be offered. * The treatment plan will be assisted using the Echolaser Smart Interface. * Depending on the shape and volume of the nodule to be treated, the investigator will determine whether one or two needles positioned parallel to each other along the longitudinal axis of the nodule will need to be used for treatment. * Under ultrasound guidance, the investigator will introduce up to two 21-gauge introducer needles through the Guide kit into the target thyroid lesion percutaneously. * Once the correct positioning of the needles has been verified under ultrasound imaging, an optical fiber is introduced into each needle with its tip protruding 5 mm out of the needle and in direct contact with the tissue to be ablated. * Laser beam emission through the flat-tipped optical fiber produces a lesion (coagulation volume) within the nodule of an ellipsoidal shape, one third of which is positioned behind the tip of the fiber, and two-thirds in front. * Each application session will last between 400 and 600 seconds under a laser source power output of 3W. An application is defined as the time between turning on and turning off the laser source. * Up to 3 applications may be carried out during the same treatment session by pulling back along the needle and fiber axis by 0.5-1.0-1.5 cm to allow for treatment of tissue area not treated with previous application. * Following completion of the laser ablation, the fibers will be removed followed by extraction of the needle(s). Hemostasis will be achieved at the site of needle insertion by applying pressure to the site. * External bleeding will be assessed by visual inspection following extraction of the needle. * Internal bleeding and potential nodule rupture will be assessed by ultrasound of the thyroid/neck with doppler flow assessment by the investigator following needle extraction using GE Logiq P6 ultrasound.The site will be covered with a sterile dressing/bandage.
Interventions
DEVICELaser ablation of benign thyroid nodule
Ablating symptomatic benign thyroid nodules using laser
Sponsors
Mercy Research
Johnson Thomas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Males or females, Age ≥18 years * Thyroid Stimulating Hormone (TSH) within normal limits * Presence of thyroid nodule \>29 mm and ≤60 mm in the longest dimension on ultrasound imaging * Symptoms from thyroid nodule - tightness or pressure in neck, neck tenderness, neck pain, difficulty swallowing, voice changes, shortness of breath or cosmetic disfigurement * Solid thyroid nodule with less than 20% cystic component * Cytological benign nodule proven by previous biopsy within 2 years * Ability to place the laser tip inside the nodule and to keep vital structures (i.e. trachea and esophagus) outside the zone of injury. To achieve this safe zone, we will leave a minimum of 17 mm distance between the fiber tip anterior to the vital structures and 10 mm from the fiber tip in all other dimensions. * Not on anticoagulants or anticoagulants stopped for appropriate amount of time based on the pharmacology of the drug * Ability to understand and willingness to provide informed consent
Exclusion criteria
* Pregnancy * Diagnosis of Hyperthyroidism * Malignant thyroid nodule * Egg shell or coarse calcification in the thyroid nodule * Patient on anticoagulation which cannot be stopped due to medical reasons * Coagulopathy * Thyroid nodules in contact with trachea, esophagus or major blood vessels * Prior neck surgery * Prior radiation to head and neck * Previous radioactive iodine treatment * Current iodine supplementation * Current anti-thyroid medication * Biotin supplementation within 2 days prior to enrollment * Allergy to Ethyl chloride spray or lidocaine * Physical and psychological conditions that prevent safe administration of the procedure as determined by the investigator * Adults not able to consent * Prisoners * Individuals who cannot read and understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale | 3 months, 6 months, and 12 months after procedure | Patients perceived cosmetic appearance will be measured using a numerical scale at baseline, immediately after procedure and then at 3, 6 and 12 months after procedure using following question. On a scale from 0 to 10, how much does your thyroid nodule affect your appearance? 0 being the best outcome and 10 being the worst outcome. |
| Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation | 12 months | Percentage change from baseline volume will be calculated at 3, 6 and 12 months after laser treatment. |
| Change in the Thyroid Function After Laser Treatment Assessed by the Measurement of TSH and Free T4 at 3, 6 and 12 Months After Laser Ablation | 12 months | Number of patients who develops hypo or hyperthyroidism 3,6 and 12 months after laser treatment. |
| Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation | 12 months | Number of patients who had changes in blood flow inside the thyroid nodule as evidenced by change in Doppler grade. |
| Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation | 12 months | Number of patients who develops new thyroid antibodies 3,6, and 12 months after laser ablation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. | Post-procedure on the day of procedure | Participants will be asked to answer the following questionnaire after the procedure. How likely is it that you would have the laser ablation procedure again? 1 = Very Likely 2 = Somewhat Likely 3 = Not Likely |
| Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 | 1 year | Treatment related adverse events will be captured using CTCAE v4,0 format |
| Reported Pain Score on the Numerical Scale 3 Months Post Procedure. | 3 months | Change in pain will be measured using a numerical scale at baseline, immediately post procedure and 3 months after procedure using the following question. Rate your pain on a scale from 0 to 10 where 0 is no pain and 10 is the worst pain possible. |
| Reported Pain Score on the Numerical Scale Immediately Post Procedure. | Immediately post-procedure | Change in pain will be measured using a numerical scale at baseline, immediately post procedure and 3 months after procedure using the following question. Rate your pain on a scale from 0 to 10 where 0 is no pain and 10 is the worst pain possible. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Patients will receive laser treatment for benign symptomatic nodules
Laser ablation of benign thyroid nodule: Ablating symptomatic benign thyroid nodules using laser | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Treatment Arm | — |
|---|---|---|
| Age, Continuous | 56 years | — |
| Baseline antithyroid antibodies Thyroglobulin Antibodies | 11 IU/mL | — |
| Baseline antithyroid antibodies TPO Antibodies | 6.8 IU/mL | — |
| Baseline Free T3 | 3.12 pmol/L | — |
| Baseline Free T4 | 1.26 ng/dL | — |
| Baseline pain score Pain score of 0 | 6 participants | — |
| Baseline pain score Pain score of 1 | 2 participants | — |
| Baseline pain score Pain score of 4 | 2 participants | — |
| Baseline status of vocal fold structure and function Presented as abnormal | 0 Participants | — |
| Baseline status of vocal fold structure and function Presented as normal | 10 Participants | — |
| Baseline symptoms Reported cosmetic disfigurement | 5 participants | — |
| Baseline symptoms Reported difficulty swallowing | 7 participants | — |
| Baseline symptoms Reported neck pain | 1 participants | — |
| Baseline symptoms Reported neck tenderness | 6 participants | — |
| Baseline symptoms Reported neck tightness | 9 participants | — |
| Baseline symptoms Reported shortness of breath | 2 participants | — |
| Baseline symptoms Reported voice changes | 2 participants | — |
| Baseline TSH | 1.22 µU/mL | — |
| Baseline visual inspection of the neck at 1 m Presented with no visible nodule at a distance of > 1 meter | 0 participants | — |
| Baseline visual inspection of the neck at 1 m Presented with visible nodule at a distance of > 1 meter | 10 participants | — |
| Baseline volume of the index thyroid nodule | 17.43 mm^3 | — |
| Cosmetic assessment at baseline | 2.7 score on a scale | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation
Number of patients who had changes in blood flow inside the thyroid nodule as evidenced by change in Doppler grade.
Time frame: 12 months
Population: 9 subjects completed the 12-month post-procedure study visit. One patient did not return for the 12-month follow up visit and was determined to be lost to follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Arm | Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation | 3 months | 1 Participants |
| Treatment Arm | Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation | 6 months | 0 Participants |
| Treatment Arm | Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation | 12 months | 0 Participants |
Primary
Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation
Percentage change from baseline volume will be calculated at 3, 6 and 12 months after laser treatment.
Time frame: 12 months
Population: 9 subjects completed the 12-month post-procedure study visit. One patient did not return for the 12-month follow up visit and was determined to be lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment Arm | Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation | Average change in volume of thyroid nodule at the 3-months post-procedure study visit | 63.4 percentage of volume reduction |
| Treatment Arm | Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation | Average change in volume of thyroid nodule from baseline to 12-months | 71.087 percentage of volume reduction |
Primary
Change in the Thyroid Function After Laser Treatment Assessed by the Measurement of TSH and Free T4 at 3, 6 and 12 Months After Laser Ablation
Number of patients who develops hypo or hyperthyroidism 3,6 and 12 months after laser treatment.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Arm | Change in the Thyroid Function After Laser Treatment Assessed by the Measurement of TSH and Free T4 at 3, 6 and 12 Months After Laser Ablation | Demonstrated a clinically significant change | 0 participants |
| Treatment Arm | Change in the Thyroid Function After Laser Treatment Assessed by the Measurement of TSH and Free T4 at 3, 6 and 12 Months After Laser Ablation | Did not demonstrate a clinically significant change | 10 participants |
Primary
Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation
Number of patients who develops new thyroid antibodies 3,6, and 12 months after laser ablation
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Arm | Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation | Demonstrated a clinically significant change | 0 participants |
| Treatment Arm | Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation | Did not demonstrate a clinically significant change | 10 participants |
Primary
Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale
Patients perceived cosmetic appearance will be measured using a numerical scale at baseline, immediately after procedure and then at 3, 6 and 12 months after procedure using following question. On a scale from 0 to 10, how much does your thyroid nodule affect your appearance? 0 being the best outcome and 10 being the worst outcome.
Time frame: 3 months, 6 months, and 12 months after procedure
Population: 9 subjects completed the 12-month post-procedure study visit. One patient did not return for the 12-month follow up visit and was determined to be lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment Arm | Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale | Reported Immediately after procedure | 3 score on a scale |
| Treatment Arm | Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale | 3 months | 0.9 score on a scale |
| Treatment Arm | Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale | 6 months | 0.6 score on a scale |
| Treatment Arm | Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale | 12 months | .78 score on a scale |
Secondary
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Treatment related adverse events will be captured using CTCAE v4,0 format
Time frame: 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Arm | Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Feeling of a knot in neck at needle stick site | 1 Participants |
| Treatment Arm | Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Sensation of lump in throat | 1 Participants |
| Treatment Arm | Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Burning sensation in neck at needle stick site | 1 Participants |
| Treatment Arm | Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Sore throat | 1 Participants |
| Treatment Arm | Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Coughing | 1 Participants |
| Treatment Arm | Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Bruising to neck | 2 Participants |
| Treatment Arm | Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Pain/discomfort with swallowing | 2 Participants |
| Treatment Arm | Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Difficulty swallowing | 1 Participants |
| Treatment Arm | Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Swelling at needle stick site | 6 Participants |
| Treatment Arm | Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Pain/soreness in neck | 10 Participants |
Secondary
Reported Pain Score on the Numerical Scale 3 Months Post Procedure.
Change in pain will be measured using a numerical scale at baseline, immediately post procedure and 3 months after procedure using the following question. Rate your pain on a scale from 0 to 10 where 0 is no pain and 10 is the worst pain possible.
Time frame: 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Arm | Reported Pain Score on the Numerical Scale 3 Months Post Procedure. | Pain score of 0 | 10 participants |
| Treatment Arm | Reported Pain Score on the Numerical Scale 3 Months Post Procedure. | Pain score greater than 0 | 0 participants |
Secondary
Reported Pain Score on the Numerical Scale Immediately Post Procedure.
Change in pain will be measured using a numerical scale at baseline, immediately post procedure and 3 months after procedure using the following question. Rate your pain on a scale from 0 to 10 where 0 is no pain and 10 is the worst pain possible.
Time frame: Immediately post-procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm | Reported Pain Score on the Numerical Scale Immediately Post Procedure. | 5.5 pain score on a scale |
Secondary
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
Participants will be asked to answer the following questionnaire after the procedure. How likely is it that you would have the laser ablation procedure again? 1 = Very Likely 2 = Somewhat Likely 3 = Not Likely
Time frame: Post-procedure on the day of procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Arm | Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. | 1 = Very Likely | 7 Participants |
| Treatment Arm | Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. | 2 = Somewhat Likely | 3 Participants |
| Treatment Arm | Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. | 3 = Not Likely | 0 Participants |
Secondary
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
Participants will be asked to answer the following questionnaire after the procedure. How satisfied were you with the length of the laser ablation procedure? 1= Satisfied 2 = Neither 3 = Dissatisfied
Time frame: Post-procedure on day of procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Arm | Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. | 1= Satisfied | 7 Participants |
| Treatment Arm | Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. | 2 = Neither | 2 Participants |
| Treatment Arm | Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. | 3 = Dissatisfied | 1 Participants |
Secondary
Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure.
Participants will be asked to answer the following questionnaire after the procedure. How much discomfort did you have with the laser ablation procedure? 1= Less than I thought 2 = About what I thought 3 = More than I thought
Time frame: Post-procedure on day of procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Arm | Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. | 1= Less than I thought | 1 Participants |
| Treatment Arm | Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. | 2 = About what I thought | 3 Participants |
| Treatment Arm | Tolerability of Ultrasound Guided Percutaneous Laser Ablation for Treatment of Symptomatic Benign Thyroid Nodules as Reported Through a Questionnaire After the Procedure. | 3 = More than I thought | 6 Participants |