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Completed

NCT Number: NCT01664936

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I

Radiation

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Correlate Cerenkov imaging

    Time frame: 2 years

    signal with uptake of the radiotracer. Cerenkov images will be correlated with images obtained from standard clinical PET/CT and scintigraphy.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2012
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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