Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Tongue Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Tongue Diseases

Tongue Cancer

Oral Cancer

3D ultrasound scanning of the resected tongue tumor will be performed. The margin analysis will be made using the 3D ultrasound image.

3D ultrasound

Fatemeh Makouei

Tobias Todsen

Tobias Todsen, MD, PhD

Complete removal of cancer encircled by a secure margin of healthy tissue is the aim of surgical oncology. A close or positive surgical margin reported by pathologist typically ends in adjuvant therapies (re-surgery and/or radiotherapy), which come with prognostic risks and financial cost. Therefore, ex-vivo imaging of removed cancer tissue may assist in margin evaluation. In this study, investigators aimed to investigate the correlation of 3D ultrasound to histopathology to assess tongue tumor margin status.

Surgical Margin Assessment by 3D Ultrasound

Feasibility of 3D Ultrasound in the Assessment of Resection Margins During Surgery for Squamous Cell Carcinoma of the Tongue: a Comparison With Histopathology

The smallest margin will be measured in mm on 3D ultrasound image of the ex-vivo surgical specimen. Correlation of the measurement to the final histopathology result will be investigated.

number of margins correctly classified as free (\> 5 mm), close (\< 5 mm) or positive (\<1 mm) margin

Rigshospitalet, Denmark

Biomedical Engineer, PhD

Lip and Oral Cavity Cancer

3D ultrasound and MR scanning of the resected tongue tumor will be performed. The resected surgical specimen will also be examined by the surgeon to assess the margins. The accuracy of the margin assessment by 3D ultrasound, MRI, and surgeon examination will be evaluated by correlating the results to the final histopathology findings.

3D ultrasound, MRI, resected specimen examination by surgeon

Fatemeh Makouei, PhD

In the current protocol, application of 3D ex-vivo ultrasound, MRI, and clinical evaluation (palpation and examination) by the surgeon is proposed to analyze the margin status in tongue squamous cell carcinoma and correlate the results to the histopathology findings.

Cancer surgery is the primary treatment in the early stages of tongue squamous cell carcinoma (SCC), and the goal is the complete resection of the tumor with an adequate margin of healthy tissue around to ensure proper cancer removal. Inadequate margins lead to a high risk of local cancer recurrence and the patient will need re-surgery or adjuvant therapies. Ex-vivo imaging of the resected surgical specimen has been suggested to provide information for margin assessment and thus improve cancer surgery. In this manuscript, a protocol to investigate the clinical benefit of three-dimensional (3D) ultrasound imaging of the surgical margins and comparing the results to magnetic resonance imaging (MRI) and the clinical examination of the surgical specimen by surgeon (palpation to inspect the resected tissue) has been designed. Tumor segmentation and margin measurement (Anterior towards apex of tongue, posterior towards base of tongue, medial towards back of tongue, lateral towards floor of mouth, and profound/deep margins) will be performed by head and neck surgeons on 3D ultrasound images and by two consultant radiologists on MRI of the ex-vivo specimen. Accuracy of each method will be evaluated by computing the proportion of correctly classified margins (positive, close, and free) by each technique with respect to the gold standard histopathology.

3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment

3D Ultrasound in the Assessment of Resection Margins During Surgery for Squamous Cell Carcinoma of the Tongue: a Comparison With Clinical Evaluation, MRI, and Histopathology

Biomedical Engineer, PhD, Assistant professor

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Hemangioma

Hemangioma, Capillary

Port-Wine Stain

Neoplasms, Vascular Tissue

Congenital Abnormalities

Skin Abnormalities

Skin Diseases

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Propranolol

Timolol

Maleic acid

Dosage of 1 mg/kg per day divided 2 times daily. Blood pressure, heart rate and oxygen saturation are monitored after propranolol initiation. Treatment is continued with a gradual increase to 2 mg/kg per day divided 2 times daily. Treatment is continued until the hemangioma no longer changes in the characteristics judged by the physicians, including, color, size, temperature and deformability.

One drop of of timolol maleate 0.5% gel is topically applied and massaged into the hemangioma twice per day . This dosage provides an estimated 0.5 mg of timolol per day. The treatment is continued until it is considered to be no longer effective as judged by the physicians.

No oral or topical treatment will be given as recommended by the treating physicians and elected by the parents. Patients will be evaluated periodically to determine what changes in treatment are warranted. If this occurs, the patients will be included in the appropriate study group.

Marty O Visscher, PhD

Denise Adams, MD

Adrienne Hammill, MD, PhD

A combined set of quantitative skin imaging methods will quantitatively describe the natural ontogeny and the response to standard treatments over time in patients with infantile hemangiomas.

Infantile hemangiomas (IH) are relatively common benign vascular neoplasms, which appear shortly after birth and grow rapidly in the following weeks and months. The proliferative phase involves a rapidly dividing endothelial cell proliferation. The tumors generally stabilize and then involute over time. They are usually clinically insignificant; however, a small percentage of them can be life threatening secondary to location, associated syndrome, and physical findings such as ulceration. Treatment options have included steroids, interferon, vincristine and more recently propranolol. There are few published prospective research studies on the effectiveness of these treatment options. Because of several factors, it has been difficult to objectively measure response of these lesions. The purpose is to determine (1) whether multiple quantitative skin imaging modalities can quantitatively describe the clinically relevant features of infantile hemangiomas, including color (red, blue), lightness, size (height, volume), biomechanical properties, temperature and perfusion and (2) the natural ontogeny and response to treatment over time. The treatments are oral propranolol, topical timolol and untreated (observation).

Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities

Ontogeny and Quantitative Multimodal Skin Imaging of Infantile Hemangiomas

IH height and volume will be obtained from surface scans with the Artec scanner with a 0.5 mm resolution, 0.1 mm accuracy, at 60 cm. Three dimensional scans will be created with the Artec Studio software and features quantified with the three dimensional software. Soft tissue landmarks will create the region of interest for all evaluations. Height and volume will be calculated for the infantile hemangioma versus the control.

Temperature information will be acquired with a thermal imaging camera with analysis software. The thermal features of the surrounding uninvolved control skin are removed by applying thresholds. Static infrared thermography captures the steady-state condition and spatial distribution. Dynamic infrared thermography applies a stress (cooling) to stimulate the thermal response within the tissue.

High resolution color Images will be taken taken with a digital camera, Micro 60 mm lens with a wireless close up flash system at 30cm and perpendicular to the site. The images are color corrected and processed into three distinct images : red color, blue-yellow color, and lightness (white - back).

Color and thermal images are co-registered and analyzed with customized software. The system creates quantitative outputs and maps for visualization of IH regions of thermal and color activity. Threshold values for the lightness, red color, blue color and thermal images are selected based upon histogram distributions of the uninvolved skin as the values above the mean and multiple standard deviations The pixels beyond the thresholds are used to quantify and map the features due to the hemangioma itself.

Tissue mechanical properties (i.e., elasticity, elastic deformation, laxity, stiffness, etc.) will be measured to assess tissue deformability. The instrument measures biomechanical properties of the skin by applying a negative pressure, in the range between 20 and 500 mbar. These properies are compared to an uninvolved contralateral control site.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgical Margin Assessment by 3D Ultrasound	NCT05740774	Tongue Cancer Squamous Cell C... Head and Neck C...	3D ultrasound	18 Years -	Rigshospitalet, Denmark
Surgical Margin Assessment by 3D Ultrasound	NCT05740774	Tongue Cancer Squamous Cell C... Head and Neck C...	3D ultrasound	18 Years -	Rigshospitalet, Denmark
3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment	NCT05843032	Squamous Cell C... Tongue SCC Head and Neck C...	3D ultrasound, ...	18 Years -	Rigshospitalet, Denmark
Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities	NCT02061735	Infantile Heman...		1 Month - 5 Years	Children's Hospital Medical Center, Cincinnati
Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities	NCT02061735	Infantile Heman...		1 Month - 5 Years	Children's Hospital Medical Center, Cincinnati

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