Clinical trial NCT03484884: A Study of Optical Imaging With Light From Radiotracers in Cancer Patients
Official title: A Feasibility Study of Non-Invasive Cerenkov Luminescence Imaging in Patients With Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Thyroid Cancer
Keywords: nodal metastases
17-538
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be identified by a member of the patient's treatment team, the protocol investigator, or research team.

Brief summary: The purpose of this study is to test Cerenkov luminescence imaging, which is a different way to take pictures of thyroid cancer and/or any tumors with (existing or suspected) nodal metastases in the neck, supraclavicular, axillary and/or inguinal region.


Eligibility criteria: Inclusion Criteria:

* Participant is 18 years of age or old
* Participant must meet one of the following:

  * Patients with thyroid cancer scheduled for thyroid ablation therapy with 131I
  * Patients with any tumors with (existing or suspected) nodal metastases in the neck, supraclavicular, axillary and/or inguinal region who are scheduled to receive a clinical FDG PET/CT scan
  * Patients with metastatic prostate cancer who are schedule for Xofigo therapy with 223Ra
  * Patients scheduled to receive a standard of care 66Ga-DOTA-TATE or \[18f\]-PARPi PET scan in the Nuclear Medicine Clinic
  * Patient undergoing Lu-DOTA TATE treatment in the Nuclear Medicine Clinic

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. Any conditions that would prevent this will exclude the patients. This includes patients who unable to sit in a dark environment, have claustrophobic, inability to sit still for a few minutes
* 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. This also includes open wounds on the area of interest.

Primary outcomes:
measure: Feasibility of clinical Cerenkov luminescence imaging by achieving satisfactory imaging at least a rate of 80%
timeFrame: Through study completion, an average of 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jan Grimm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pratt EC, Skubal M, Mc Larney B, Causa-Andrieu P, Das S, Sawan P, Araji A, Riedl C, Vyas K, Tuch D, Grimm J. Prospective testing of clinical Cerenkov luminescence imaging against standard-of-care nuclear imaging for tumour location. Nat Biomed Eng. 2022 May;6(5):559-568. doi: 10.1038/s41551-022-00876-4. Epub 2022 Apr 11.