Head and Neck CancersNCT01664936
Non-Invasive Cerenkov Luminescence Imaging of Lymphoma, Leukemia and Metastatic Lymph Nodes
An observational study of Head and Neck Cancers, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see if a new way of imaging called the Cerenkov luminescence or effect that is used with a standard clinical PET/CT and/or investigation scans can be done in order to capture tumor sizes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancers
- What is being tested?
- Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2012to 3 Apr 2018
- 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: MSKCC Clinics
Who may be able to join
- Participant is 18 years of age or older.
- Participant is scheduled for standard clinical and/or investigational PET/CT scan or 131I therapy within the Nuclear Medicine Service at Main Hospital.
- Patients must have had pathologic lymph node metastases in the neck, axillary or inguinal area (do not need to be biopsy proven) from either leukemias, lymphomas: , Head and Neck cancers (e.g. tonsillar, nasopharynx, tongue carcinoma, breast cancer or melanoma;or lymphoma or tonsillar or squamous cell carcinoma with metastases in the neck region for PET/CT imaging, or thyroid cancer for thyroid ablation therapy. Any other more infrequent cancer metastasizing with nodal metastasis in the neck, axilla and inguinal regions to cervical lymph nodes is eligible as well as the primary goal is to image pathological (i.e. hypermetabolic) lymph nodes.
- Patients with hypermetabolic activity and uptake in the neck,axilla, breast and inguinal region on scan, defined visually as significant lesion suspicious for malignancy by a nuclear medicine physician or trainee. (We will include a subset of patients with normal lymph nodes during screening. This subset of patients will be imaged as a negative control for this study.)
Who cannot join
- Patients imaged for Cerenkov luminescence are going to be required to be in a darkened enclosure for at least 10 minutes and sit still during image acquisition, potentially covered by a dark cloth in case that the ambient light level remains too high for the ultra-sensitive camera. Any conditions that would prevent this will exclude the patients.
- There are any other past medical, physiological or demographic concerns. This includes any patients with skin blemishes that are present at the dermis over the tumor, as these are of particular interest for use of this technique.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to see if a new way of imaging called the Cerenkov luminescence or effect that is used with a standard clinical PET/CT and/or investigation scans can be done in order to capture tumor sizes. The investigators believe endoscopies and surgical procedures could benefit from this type of imaging in the future. The Cerenkov imaging could be used as a guide for surgical resections.
The purpose of this study is to use the Cerenkov light from FDG, Iodine-131 tracer sand/or other investigational tracers to image tumors and its sizes in the head, neck, breast, axillary and pelvic regions with a highly sensitive camera. The investigators will be trying to see if we can get another picture of the tumor using the Cerenkov light as part of the standard clinical scan or therapy.
- Conditions
- Head and Neck Cancers
- Being tested
- Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I
- Keywords
- 18F-FDG PET/CT scan, 131I therapy, Cerenkov Luminescence Imaging, 12-050, Lymphoma, Leukemia, Metastatic Lymph Nodes
- Medical subject headings
- Head and Neck Neoplasms, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131IRadiation
We will image (i) patients who are receiving a PET/CT scan for tumors in the head / neck region and (ii) patients with thyroid cancer after 131I radioablation. Two scans will be completed per patient, one of the primary tumors, as well as a 'background' scan of the contralateral side or, if tumor is there as well, of the forearm. The device to be used is an intensified charge-coupled device camera (Stanford Photonics, Palo Alto, CA) connected to a laptop PC. The camera will use a Quartz high-UV transmission 50 mm 0.8f lens. The Imaging device will be placed approximately 5 cm from the area of the patient to be imaged.
| Study group | Role | What they receive |
|---|---|---|
| pts receiving a PET/CT scan with Metastatic LNs | This study seeks to optically image the Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I in a cohort of patients with primary tumor sites and from pathologic lymph nodes after routine 18F-FDG PET 31I radiotherapy and/or investigational study scans. We will include a subset of patients with normal lymph nodes during screening. This subset of patients will be imaged as a negative control for this study. Receives: Radiation: Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of clinical Cerenkov imaging
is to assess the feasibility of clinical Cerenkov luminescence imaging using current clinical radiotracers (18F-FDG and 131I) and a highly sensitive camera.
Measured: 2 years
Secondary outcomes (1)
Correlate Cerenkov imaging
signal with uptake of the radiotracer. Cerenkov images will be correlated with images obtained from standard clinical PET/CT and scintigraphy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study start8 Aug 2012
- Primary completion3 Apr 2018
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancersStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jan Grimm, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664936
- Sponsor's protocol ID
- 12-050
- Status last verified
- Apr 2018
- First submitted
- 10 Aug 2012
- Last updated
- 6 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Cerenkov Luminescence Imaging of Lymphoma, Leukemia and Metastatic Lymph Nodes
- ClinicalTrials.gov ID
- NCT01664936
- Acronym / sponsor ID
- 12-050
- Conditions
- Head and Neck Cancers
- Keywords
- 18F-FDG PET/CT scan, 131I therapy, Cerenkov Luminescence Imaging, 12-050, Lymphoma, Leukemia, Metastatic Lymph Nodes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 8 Aug 2012 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 14 Aug 2012 (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.
The purpose of this study is to see if a new way of imaging called the Cerenkov luminescence or effect that is used with a standard clinical PET/CT and/or investigation scans can be done in order to capture tumor sizes. The investigators believe endoscopies and surgical procedures could benefit from this type of imaging in the future. The Cerenkov imaging could be used as a guide for surgical resections.
The purpose of this study is to use the Cerenkov light from FDG, Iodine-131 tracer sand/or other investigational tracers to image tumors and its sizes in the head, neck, breast, axillary and pelvic regions with a highly sensitive camera. The investigators will be trying to see if we can get another picture of the tumor using the Cerenkov light as part of the standard clinical scan or therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pts receiving a PET/CT scan with Metastatic LNs | – | Radiation: Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131IThis study seeks to optically image the Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I in a cohort of patients with primary tumor sites and from pathologic lymph nodes after routine 18F-FDG PET 31I radiotherapy and/or investigational study scans. We will include a subset of patients with normal lymph nodes during screening. This subset of patients will be imaged as a negative control for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC Clinics
Key inclusion criteria (4 listed)
- Participant is 18 years of age or older.
- Participant is scheduled for standard clinical and/or investigational PET/CT scan or 131I therapy within the Nuclear Medicine Service at Main Hospital.
- Patients must have had pathologic lymph node metastases in the neck, axillary or inguinal area (do not need to be biopsy proven) from either leukemias, lymphomas: , Head and Neck cancers (e.g. tonsillar, nasopharynx, tongue carcinoma, breast cancer or melanoma;or lymphoma or tonsillar or squamous cell carcinoma with metastases in the neck region for PET/CT imaging, or thyroid cancer for thyroid ablation therapy. Any other more infrequent cancer metastasizing with nodal metastasis in the neck, axilla and inguinal regions to cervical lymph nodes is eligible as well as the primary goal is to image pathological (i.e. hypermetabolic) lymph nodes.
- Patients with hypermetabolic activity and uptake in the neck,axilla, breast and inguinal region on scan, defined visually as significant lesion suspicious for malignancy by a nuclear medicine physician or trainee. (We will include a subset of patients with normal lymph nodes during screening. This subset of patients will be imaged as a negative control for this study.)
Key exclusion criteria (2 listed)
- Patients imaged for Cerenkov luminescence are going to be required to be in a darkened enclosure for at least 10 minutes and sit still during image acquisition, potentially covered by a dark cloth in case that the ambient light level remains too high for the ultra-sensitive camera. Any conditions that would prevent this will exclude the patients.
- There are any other past medical, physiological or demographic concerns. This includes any patients with skin blemishes that are present at the dermis over the tumor, as these are of particular interest for use of this technique.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131IWe will image (i) patients who are receiving a PET/CT scan for tumors in the head / neck region and (ii) patients with thyroid cancer after 131I radioablation. Two scans will be completed per patient, one of the primary tumors, as well as a 'background' scan of the contralateral side or, if tumor is there as well, of the forearm. The device to be used is an intensified charge-coupled device camera (Stanford Photonics, Palo Alto, CA) connected to a laptop PC. The camera will use a Quartz high-UV transmission 50 mm 0.8f lens. The Imaging device will be placed approximately 5 cm from the area of the patient to be imaged. | Radiation | pts receiving a PET/CT scan with Metastatic LNs |
Primary outcome
feasibility of clinical Cerenkov imaging
Time frame: 2 years
is to assess the feasibility of clinical Cerenkov luminescence imaging using current clinical radiotracers (18F-FDG and 131I) and a highly sensitive camera.
1 secondary outcome
Correlate Cerenkov imaging
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Jan Grimm, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
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 Head and Neck Cancers, run by Memorial Sloan Kettering Cancer Center 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 6 Apr 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
feasibility of clinical Cerenkov imaging (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 6 Apr 2018.