CLINICAL TRIAL

Photoacoustic Imaging for Oral Squamous Cell Carcinoma

Recruiting · 18+ · All Sexes · Buffalo, NY

This study is evaluating whether photoacoustic imaging can be used to measure tumors and normal tissue in patients with head and neck cancer.

See full description

About the trial for Oral Squamous Cell Carcinoma

Eligible Conditions
Head and Neck Carcinoma · Carcinoma · Laryngeal Neoplasms · Squamous Cell Carcinoma of Head and Neck · Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) · Radiation Therapy Recipient · Head and Neck Lymph Node

Treatment Groups

This trial involves 2 different treatments. Photoacoustic Imaging is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Transcutaneous Acupoint Electrical Stimulation
PROCEDURE
Photoacoustic Imaging
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Acupoint Electrical Stimulation
2014
N/A
~30

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) getting chemoradiation therapy
Presence of neck nodes or laryngeal tumor superficial enough (within 2-3 cm of skin surface) to allow imaging by photoacoustic ultrasound (PA-US)
No restriction on race or ethnic background
Subject must understand the investigational nature of the study and sign an independent ethics committee/institutional review board approved written informed consent prior to receiving any study related procedure
History of prior radiation therapy with xerostomia requiring ALTENS
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Photoacoustic Imaging will improve 2 primary outcomes and 2 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of Up to 6 months after treatment completion.

Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate
UP TO 6 MONTHS AFTER TREATMENT COMPLETION
Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.
UP TO 6 MONTHS AFTER TREATMENT COMPLETION
Changes in hemoglobin (hbt) measurements
UP TO 2 YEARS
Compare hemoglobin measurements between baseline until end of study
UP TO 2 YEARS
Utility of serial PAI-based oxygen saturation (%sO2) measurements
UP TO 2 YEARS
Descriptive statistics (means, medium) will be used to summarize percent of SO2
UP TO 2 YEARS
Feasibility of PAI to quantify tumor characteristic in patients undergoing ALTENS (part II): rate
UP TO 2 YEARS
Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.
UP TO 2 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can oral squamous cell carcinoma be cured?

Although the proportion of patients with advanced OSCC is diminishing, OSCC does present a very serious problem in terms of its recurrence and mortality. The use of adjuvant chemoradiotherapy is an alternative treatment approach that can improve survival and quality of life in OSCC patients.

Anonymous Patient Answer

How many people get oral squamous cell carcinoma a year in the United States?

The American Cancer Society estimates there will be 10,100 new diagnoses of oral squamous cell carcinoma in 2017. The oral cancer population has been increasing steadily since 1940. The 5-year relative survival rate from 1971 through 1990 was 35%. By comparison, the 5-year relative overall survival rate from 1975 through 1990 was 41%. Oropharyngeal cancer had the strongest association with smoking and drinking behavior at all time periods. At each 5-year period from 1970 through 2010, an increasing number of people had a curative treatment at time of diagnosis; moreover, the percentage of individuals with curative treatment increased steadily. These trends are most evident for pharyngeal cancers.

Anonymous Patient Answer

What are common treatments for oral squamous cell carcinoma?

A thorough knowledge about the treatment of OSCC is essential for patient's care and cancer survival. The best outcome of treatment depends on the stage, the extent of pathology, and the patients' medical and socioeconomic status. The patient may become compromised by the treatment; therefore, appropriate communication and emotional consultation are especially important.

Anonymous Patient Answer

What causes oral squamous cell carcinoma?

Oral SCC is caused primarily by smoking and other factors that increase the likelihood of smoking. Most of the other factors increase the chance of developing OSCC, but not necessarily cancer. However, a small number of risk factors clearly do elevate the chances of cancer and can be targeted to prevent the tumors. One of the risk factors clearly alters the probability of cancer developing in the mouth and can be targeted as well.

Anonymous Patient Answer

What is oral squamous cell carcinoma?

Oral squamous cell carcinoma develops in the oral cavity, usually in and around the mouth. Oral carcinoma also develops gradually over many years. The cancer may grow and spread at any time to other parts of the body. Usually the first clinical detection of oral squamous cell carcinoma is by observing a lump on the surface of the oral cavity or gums. The disease can often be diagnosed quite early by the appearance of an ulcer. Later a lump which has grown at a suspicious spot may be noted. The occurrence of signs of oral cancer in an adult is rare. In some individuals, an individual inherits a high chance of getting oral cancer due to a genetic predisposition for the disease.

Anonymous Patient Answer

What are the signs of oral squamous cell carcinoma?

Oral cancer is a significant disease entity with significant disability, economic burden, and death. A multidisciplinary approach, early diagnosis, and prevention are important in halting future disease progression.

Anonymous Patient Answer

What is the average age someone gets oral squamous cell carcinoma?

The average age when people development oral squamous cell carcinoma is 65.2 years old. The average time of survivals is 5.2 years after the time of diagnosis by oral physician. The ratio of males to females is 1.7 to 1.

Anonymous Patient Answer

Does oral squamous cell carcinoma run in families?

Based on this observational study, there was no clear association between oral cancer and relatives with the same cancer type. However, when adjusted for family history, paternal relationship and smoking history, there was a weak positive association of paternal oral cancer with OSCC in offspring, although not statistically significant (p = 0.23).

Anonymous Patient Answer

What is the primary cause of oral squamous cell carcinoma?

The strongest factors that determined risk of OSCC in this investigation were cigarette smoking and alcohol drinking. In addition, the presence of one or more oral lichen planus lesions, a history of radiation therapy to the head and neck region, and a family history of oral cancer were also found to be risk factors for development of oral cancers.

Anonymous Patient Answer

What is the survival rate for oral squamous cell carcinoma?

There is a trend in survival for the different types of squamous cell carcinomas. Data from a recent study the relative survival for oral squamous cell carcinoma was better. The cause of this improvement is unclear, although it is most likely to be due to the better quality of the treatment and a better detection and treatment of the disease in this group of patients who do not fit neatly into the previously described histopathology classes.

Anonymous Patient Answer

Who should consider clinical trials for oral squamous cell carcinoma?

Clinically eligible patients with surgically resectable OSCC have high likelihoods of benefit with different protocols. This indicates the need for well-designed trials to more accurately determine the efficacy of these protocols in treating both locally advanced and primary stage OSCC patients. Clin J Surg Oncol. 2016;24:837-850.

Anonymous Patient Answer

How does photoacoustic imaging work?

As our data show, the spectral photoacoustic (PA) signal amplitude is linearly related to the optical intensity of the imaging illumination. The signal amplitude is also linearly dependent on the irradiance. Photodynamic therapy with an iodide-based photosensitizer should therefore suffice to induce PA signal enhancement in an appropriate optical-density range. Given the close proximity to the light source, the photothermal signal is also linearly related to the optical intensity. Therefore, PA signal enhancement might not be restricted to the optical dose range determined for light-induced photodynamic therapy with an iodide-based photosensitizer.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Oral Squamous Cell Carcinoma by sharing your contact details with the study coordinator.