Squamous Cell Carcinoma of the Head and NeckNCT01133262
Effectiveness in Head and Neck Cancer Detection Using Positron Emission Tomography (PET) Insert Device
An observational study of Squamous Cell Carcinoma of the Head and Neck, run by Washington University School of Medicine at 1 site in United States.
Trial summary
We have developed a prototype PET insert device that can be integrated into a clinical PET/computed tomography (CT) scanner to improve its image resolution to approximately 2.5 mm in all 3 dimensions within a reduced imaging field of view (FOV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2011
- 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 biopsy proven squamous cell carcinoma of the head and neck with suspected lymph node metastasis
Who may be able to join
- Patients must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck with suspected lymph node metastasis. Subjects with histological confirmation of squamous cell carcinoma from a lymph node biopsy in the head and neck region for carcinoma of unknown primary would also be eligible.
- Patient must be scheduled to receive (or have already received) clinical whole body PET/CT scan from a Siemens Biograph 40 PET/CT scanner as their standard of care staging.
- Patient must be scheduled to receive surgical removal of the primary tumor and the regional lymph nodes. It is preferred that the surgery will occur within 21 days of research PET imaging.
- Age >18 years, as head and neck cancer is extremely rare in children.
- Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document.
- Not currently pregnant or nursing: Female subjects must be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), or post menopausal (cessation of menses for more than 1 year). If of childbearing potential, a urine pregnancy test must be performed within the 24 hour period immediately prior to administration of 18FDG and determined to be negative
Who cannot join
- The subject weight will be limited to 250 lbs and below due to the size limitations of the prototype PET insert device.
- Subjects who are claustrophobic
- Subjects with poorly controlled diabetes (fasting blood glucose >200mg/dL)
- Subjects with prior head/neck surgery or radiation as this may disturb the natural architecture of the tissues and impede the imaging analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness in Head and Neck Cancer Detection Using PET Insert Device
We have developed a prototype PET insert device that can be integrated into a clinical PET/computed tomography (CT) scanner to improve its image resolution to approximately 2.5 mm in all 3 dimensions within a reduced imaging field of view (FOV). This zoom-in imaging capability provides 6-fold improvement in volumetric image resolution over the current state-of-the-art clinical PET scanner, offering a tremendous opportunity for cancer imaging applications, in particular for those cases where a lymph node involvement will drastically alter the patient management plan. Accurate diagnosis and staging of head-and-neck cancer is known to be challenging because of the complex anatomy and large number of lymph nodes involved in this region. As a result, head and neck cancer imaging is an ideal candidate for evaluating the clinical usefulness of this novel imaging device.
Read the detailed description
In this project, we propose to conduct an exploratory clinical trial to investigate the effectiveness of this novel imaging device in detecting small lesions and lymph node involvements in the head and neck region, and compare its results to those obtained from a clinical PET/CT scanner. More specifically, we propose to (1) recruit 5 patients who have confirmed head and neck cancer and are scheduled to receive a whole-body PET/CT scan followed by surgical operation to remove the primary tumor and the regional lymph nodes. These patients will be imaged by a state-of-the-art PET/CT scanner using the standard whole-body PET/CT imaging protocol as standard of care for initial staging. On another day, following consent to participate in this research protocol, A patient will undergo images of the head and neck region using the same type scanner with and without our novel PET insert device attached; (2) The images obtained from the PET insert device will be reviewed by experienced nuclear medicine physicians to identify the extent of lymph node involvement. The PET insert images will be compared to the standard clinical PET/CT images. A detailed image obtained for purposes of research, centered at the level of the head and neck, acquired for approximately 3 times the length of time the standard clinical image is obtained for will also be compared to the PET insert image. Images will also be compared to the pathology report of the surgically removed specimen. (3) Estimate the performance of lesion detection for different sizes of tumors using the standard PET/CT scanner as well as the PET insert device.
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startJun 2010
- Study completionDec 2011 (estimated)
Why it stopped: Feasibility/pilot study of 5 subjects registration not required
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan-Chuan Tai, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133262
- Sponsor's protocol ID
- WashU-Tai10
- Status last verified
- Mar 2015
- First submitted
- 26 May 2010
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness in Head and Neck Cancer Detection Using PET Insert Device
- ClinicalTrials.gov ID
- NCT01133262
- Acronym / sponsor ID
- WashU-Tai10
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Feasibility/pilot study of 5 subjects registration not required
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2010
- Study completion
- Dec 2011 (estimated)
- First posted
- 28 May 2010 (estimated)
- 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.
We have developed a prototype PET insert device that can be integrated into a clinical PET/computed tomography (CT) scanner to improve its image resolution to approximately 2.5 mm in all 3 dimensions within a reduced imaging field of view (FOV). This zoom-in imaging capability provides 6-fold improvement in volumetric image resolution over the current state-of-the-art clinical PET scanner, offering a tremendous opportunity for cancer imaging applications, in particular for those cases where a lymph node involvement will drastically alter the patient management plan. Accurate diagnosis and staging of head-and-neck cancer is known to be challenging because of the complex anatomy and large number of lymph nodes involved in this region. As a result, head and neck cancer imaging is an ideal candidate for evaluating the clinical usefulness of this novel imaging device.
Detailed description
In this project, we propose to conduct an exploratory clinical trial to investigate the effectiveness of this novel imaging device in detecting small lesions and lymph node involvements in the head and neck region, and compare its results to those obtained from a clinical PET/CT scanner. More specifically, we propose to (1) recruit 5 patients who have confirmed head and neck cancer and are scheduled to receive a whole-body PET/CT scan followed by surgical operation to remove the primary tumor and the regional lymph nodes. These patients will be imaged by a state-of-the-art PET/CT scanner using the standard whole-body PET/CT imaging protocol as standard of care for initial staging. On another day, following consent to participate in this research protocol, A patient will undergo images of the head and neck region using the same type scanner with and without our novel PET insert device attached; (2) The images obtained from the PET insert device will be reviewed by experienced nuclear medicine physicians to identify the extent of lymph node involvement. The PET insert images will be compared to the standard clinical PET/CT images. A detailed image obtained for purposes of research, centered at the level of the head and neck, acquired for approximately 3 times the length of time the standard clinical image is obtained for will also be compared to the PET insert image. Images will also be compared to the pathology report of the surgically removed specimen. (3) Estimate the performance of lesion detection for different sizes of tumors using the standard PET/CT scanner as well as the PET insert device.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy proven squamous cell carcinoma of the head and neck with suspected lymph node metastasis
Key inclusion criteria (6 listed)
- Patients must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck with suspected lymph node metastasis. Subjects with histological confirmation of squamous cell carcinoma from a lymph node biopsy in the head and neck region for carcinoma of unknown primary would also be eligible.
- Patient must be scheduled to receive (or have already received) clinical whole body PET/CT scan from a Siemens Biograph 40 PET/CT scanner as their standard of care staging.
- Patient must be scheduled to receive surgical removal of the primary tumor and the regional lymph nodes. It is preferred that the surgery will occur within 21 days of research PET imaging.
- Age >18 years, as head and neck cancer is extremely rare in children.
- Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (4 listed)
- The subject weight will be limited to 250 lbs and below due to the size limitations of the prototype PET insert device.
- Subjects who are claustrophobic
- Subjects with poorly controlled diabetes (fasting blood glucose >200mg/dL)
- Subjects with prior head/neck surgery or radiation as this may disturb the natural architecture of the tissues and impede the imaging analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Related trials for Squamous Cell Carcinoma of the Head and Neck
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 2
Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 1/2
A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors
Locally Advanced or Metastatic Solid Tumors
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
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.
Yuan-Chuan Tai, PhD principal investigator
Washington University School of Medicine
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 Squamous Cell Carcinoma of the Head and Neck, run by Washington University School of Medicine at 1 site in United States.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 10 Mar 2015. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 10 Mar 2015.