Non-Invasive Cerenkov Luminescence Imaging of Lymphoma, Leukemia and Metastatic Lymph Nodes

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01664936
First received: August 10, 2012
Last updated: May 11, 2016
Last verified: May 2016
  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 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.


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: 60
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Radiation: Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I
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.

  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 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.)

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
National Institutes of Health (NIH)
Investigators
Principal Investigator: Jan Grimm, MD, PhD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
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: May 11, 2016
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
Neoplasms
Neoplasms by Site
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals

ClinicalTrials.gov processed this record on May 25, 2016