Non-Invasive Cerenkov Luminescence Imaging of Lymphoma, Leukemia and Metastatic Lymph Nodes
This study is currently recruiting participants.
Verified February 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01664936
First received: August 10, 2012
Last updated: February 8, 2013
Last verified: February 2013
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Purpose
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 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 or Iodine-131 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.
| Condition | Intervention |
|---|---|
|
Head and Neck Cancers |
Radiation: Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Non-Invasive Cerenkov Luminescence Imaging of Lymphoma, Leukemia and Metastatic Lymph Nodes |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- feasibility of clinical Cerenkov imaging [ Time Frame: 2 years ] [ Designated as safety issue: No ]is to assess the feasibility of clinical Cerenkov luminescence imaging using current clinical radiotracers (18F-FDG and 131I) and a highly sensitive camera.
Secondary Outcome Measures:
- Correlate Cerenkov imaging [ Time Frame: 2 years ] [ Designated as safety issue: No ]signal with uptake of the radiotracer. Cerenkov images will be correlated with images obtained from standard clinical PET/CT and scintigraphy.
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
pts receiving a 18F-FDG 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 tumors in the pathologic lymph nodes in the neck, axilla or inguinal region as well as primary breast tumors.
|
Radiation: Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I
We will image (i) patients who are receiving a 18F-FDG 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
MSKCC Clinics
Criteria
Inclusion Criteria:
- Participant is 18 years of age or older.
- Participant is scheduled for standard clinical 18F-FDG PET/CT scan or 131I therapy within the Nuclear Medicine Service at Main Hospital.
- Patients must have 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.
Exclusion Criteria:
- 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 no 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664936
Contacts
| Contact: Jan Grimm, MD, PhD | 646-888-3095 | |
| Contact: Heiko Schöder, MD | 212-639-2079 |
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Jan Grimm, MD, PhD 646-888-3095 | |
| Contact: Heiko Schöder, MD 212-639-2079 | |
| Principal Investigator: Jan Grimm, MD, PhD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Jan Grimm, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01664936 History of Changes |
| Other Study ID Numbers: | 12-050 |
| Study First Received: | August 10, 2012 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
18F-FDG PET/CT scan 131I therapy Cerenkov Luminescence Imaging 12-050 |
Lymphoma Leukemia Metastatic Lymph Nodes |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Leukemia Lymphoma Neoplasms by Site Neoplasms |
Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013