Performing Department
Small Animal Clinical Sciences
Non Technical Summary
Oncologists often continue ineffective treatments because they lack an effective, inexpensive tool to measure patient response early in cancer treatment. There is a growing body of evidence that dynamically measuring the uptake of radiotracers in malignant tumors with PET scanners can predict ineffective cancer treatments early. Unfortunately, dynamic PET scans are not clinically practical or affordable.A new, hand-held devicecan dynamically assess tumor uptake of radiotracers to track the response to various treatment modalities. By comparingthe device'spre-treatment and early treatment dynamic assessments, oncologists can potentially identify ineffective therapy much sooner, enabling the oncologist to switch to another treatment plan. The device is uniquely positioned to benefit patients and physicians as well as reduce healthcare costs and aid underserved markets. It can also be used to speed oncology drug development, aid academic research, and improve veterinary medicine. All these applications benefit from the device's non-invasiveness, portability, low cost, ease-of-use, rapid assessment capability, simple integration with existing standards of care, and sensitivity which minimizes radiotracer doses. Bench data confirms the device can sense gamma radiation, allowing the device to interface with any radiotracer used with PET scanners. With human patients,physicians haveplaced the device sensor(s) over tumors pre-treatment and captured radiotracer uptake. Then, early in a patient's treatment, sensors are placed as closely as possible to their pre-treatment positions and a follow-up assessment captures uptake. The resulting comparisons, even without assuring exact sensor placement, suggests the device, when interfacing with 18FDG (a radiotracer indicating metabolic activity) can assess tumor response to chemotherapy early in the treatment process. In patients receiving external radiation treatment or combination of chemotherapy and radiation treatment, the device appears to confirm that the glucose-based 18FDG is ill-suited to assess tumor response. Since external radiation causes inflammation and thus a higher metabolic rate in the tumor area of interest, increased 18FDG uptake masks tumor response. FLT, a radiotracer that reveals high rates of proliferation rather than metabolism, would be a preferred radiotracer to assess tumor response in patients undergoing external radiation treatments or combination chemotherapy and radiation treatment. Withthis limited study,we seek to assess the device's ability to assess tumor response using FLT and 18FDG and to assess the impact that sensor placement plays in tumor assessment accuracy, using dogs with spontaneous thyroid carcinoma undergoing external radiation standard of care. By showing that the device is compatible with FLT and by better understanding the role that sensor placement plays in assessing tumor response,the devicecan be optimized for clinical use with patients undergoing chemotherapy, radiation, or a combination treatment. Confidential company; 10/28/13 - 10/27/15; $8,760
Animal Health Component
25%
Research Effort Categories
Basic
25%
Applied
50%
Developmental
25%
Goals / Objectives
Assessa device's ability to assess tumor response using FLT and 18FDG imaging tracers. Determine the in vivo capabilities of the device interfacing with FLT and compare FLT with FDG in assessing tumor response in patients treated with external radiation. Assess the impact that sensor placement plays in tumor assessment accuracy, using dogs with spontaneous thyroid carcinoma undergoing external radiation standard of care. Determine quantitatively the impact that sensor location plays in vivo on capturing radiotracer uptake. By showing that the device is compatible with FLT and by better understanding the role that sensor placement plays in assessing tumor response,the devicecan be optimized for clinical use with patients undergoing chemotherapy, radiation, or a combination treatment. By comparing intra-dynamic assessment and inter-dynamic assessment readings,we will quantify the role sensor location plays in reproducibility of the device output.
Project Methods
Afterdynamic assessments of 60 min using injections of 18FDG on day 0 and FLT on day 1, four dogs with thyroid carcinoma will undergo the standard of care, three weeks of external radiation. Prior to radiation treatments 14 and 15, the dogs will undergo additional follow-up dynamic assessments using 18FDG and FLT respectively. Dynamic assessment results will be compared to assess tumor response and documented. Dogs will be followed for clinical results over the following eight months and then compared to dynamic assessment results. At time 30 min, during day 0 and day 14 dynamic assessments using 18FDG, the tumor sensor will be moved three millimeters to the right or the left depending on tumor location on the dog's neck and remain there for ten minutes. At time 40 min of these same assessments, the tumor sensor will be moved an additional three millimeters in the same direction as the first movement from the original placement and remain there for ten minutes. At time 50 min, the sensor will be moved back to the original location. A photographic record of the sensor in the original location and after the first or second movement shall be taken to capture the location change in relation to the tumor. By comparing intra-dynamic assessment and inter-dynamic assessment readings Lucerno will quantify the role sensor location plays in reproducibility of the device output. The dynamic uptake of 18FDG and FLT in 4 dogs with thyroid carcinoma will be measured using the following standardized experimental conditions: Dogs will be•fasted for a minimum of 12 hr • maintained in a state of rest as much as possible prior to theirassessments and especially for the 60 min prior toassessment • placed under general anesthesia. Sensors will be applied to shaved locations on the skin above the tumor, triceps on non-injection leg, quadriceps of the back leg, and skull and data collection will be initiated on thedevice.Sensor location will be marked by outlining the sensor as required with indelible marker to ensure accurate placement during follow-up assessments. The tumor location will have two additional marks 3 mm and 6 mm to one side to facilitate location changes during the two 18FDG assessments on each dog.18FDG or FLT will be injected and data collection will cease at 60 min.