PET Core

Housed under the Yale Bioimaging Institute, the PET core is a revenue-neutral (fee-for-service) inter-institutional service provider.

The Yale PET Core is an FDA-registered radiotracer manufacturing and imaging facility that supports molecular imaging research. It conducts over 1,000 human scans and 300 small animal scans annually, supporting more than 120 clinical research and 11 animal imaging protocols across 21 departments. The core is a key resource for NIH-funded research at Yale and throughout New England. Equipped with a GE PETtrace cyclotron, radiochemistry lab developing PET radiopharmaceuticals with common isotopes (11C, 15O, 13N, 18F), and eight PET scanners dedicated to research, the facility includes systems for both human and preclinical studies. The PET Core's experienced staff enables investigators to perform advanced PET research, even without full technical expertise.

Positron Emission Tomography (PET) is a non-invasive diagnostic scanning technique that provides visual images of organ function (including blood flow, oxygen consumption, glucose metabolism, and concentrations of molecules in the brain and body tissues). During the scanning process, small amounts of radioactive compounds are injected into the body where they are absorbed by organs and tissues. The PET scanner picks up signals from the radioactive tracers and detects biochemical changes in metabolic processes that aid in disease diagnosis. Other diagnostic techniques such as CT and MRI scans can only detect structural changes after tissue damage has occurred.

Disease Diagnosis

PET scans are utilized to diagnose heart disease, brain tumors, stroke, cancer, epilepsy, head injuries, Parkinson’s disease, and many other disorders. By measuring blood flow to the heart, PET scans can be used to diagnose disorders such as coronary artery disease. PET scans can also help to determine the extent of muscle damage caused by a heart attack. One of the most significant advantages of PET is its ability to detect biochemical changes in body tissues before structural damage occurs from disease. This information allows clinicians to be proactive in their treatments.

Treatment Monitoring

Clinicians use PET scans to measure the effectiveness of current disease treatments. Scans taken at various intervals during drug therapy can demonstrate whether the medication is working, or if the treatment should be modified. Post-treatment scans evaluate the effectiveness of the treatment and can also identify early signs of disease recurrence.

Research

Research scientists use PET scans to study brain activity and chemical mechanisms involved in diseases such as schizophrenia, depression, Alzheimer’s disease, alcohol dependence, and substance abuse. By studying tissue concentrations of the absorbed radiotracer, scientists can determine if the tracer is effectively reaching molecular targets. This information can aid scientists in the development of new medications and dosing regimens.

A radioactive tracer is produced in a cyclotron machine, attached to a naturally occurring body compound (such as glucose), and administered to the patient intravenously. The tracer is absorbed by the body and concentrates in tissues and organs.

The patient lies on a table that slides slowly through a PET scanner. As the patient slides through the circular opening of the scanner, the tracer emits radioactive signals. These signals are recorded by multiple rings of detectors in the scanner and are converted into three-dimensional computer images of tissue concentrations and organ function.

Levels of tissue concentrations and organ function are represented by different colors or degrees of brightness on computer-generated PET images. Some radioactive tracer will be seen in normal tissues because healthy tissues use glucose for energy. Cancerous tumors utilize more glucose than normal tissues and will appear much brighter.

Once the scanning session has been completed, a specially trained radiologist will interpret the scan, record their findings, and forward this information to the referring physician to discuss with their patient.

• Identifies early biochemical markers of disease before structural changes in body organs occur.
• Provides an opportunity for earlier and more specific diagnosis, intervention, and treatment of disease. (CT and MRI detect structural changes after damage has occurred).
• Enables researchers to detect early biomarkers of disease that can aid in drug development.

• PET Scans (for humans, large and small animals)
• Radiosynthesis
• Validation
• Pharmacokinetic study
• Metabolite sampling
• Blood sampling
• Regulatory filing
• NHP usage
• Medical services (a-line placement, EKG, health & physical intake)

Step 1: Consult with a PET Center faculty member to discuss your research ideas to determine the potential impact of PET imaging on your unique research project and the feasibility of collaboration.

Step 2: Draft a research protocol using the PET guidelines found below for required protocol and consent language and follow our recommendations to facilitate the PET Center, MRRC, HIC, and RSC protocol review/approval processes.

Step 3: Ensure that investigators and research staff complete the required HIPAA and MRRC training before the protocol start date.

Step 4: Schedule a Protocol Initiation meeting with the PET Center and follow procedures for scheduling PET scans using the appropriate forms and send them to pet.center@yale.edu.

Please review the documents linked below for detailed instructions and forms

• PET Investigators Guide 2020-08
• PET Investigators Guide Addendum-Forms-2019-01
• PET Investigators Guide Grant Info-2022-07
• PET Center Human Imaging Policy
• PET Center Protocol Initiation Form
• FY25 Academic and Industry Sponsored Price List
• FY25 External Non-Profit Price List
• For external For-Profit pricing please email Maribel Rayas (maribel.rayas@yale.edu) and Leigh Nerka (leigh.nerka@yale.edu)
• NOT-OD-16-011 - Implementing Rigor and Transparency
• Authentication Plan for Radiotracers

Prior to initiating/scheduling a new PET protocol you are required to complete a Protocol Initiation Form and submit to: pet.scheduling@yale.edu

Once received, you will be contacted to schedule a protocol kick-off meeting. The purpose of this meeting is to confirm all PET procedures, including verification of key staff involved, level of medical coverage required, and scheduling requirements. The PI is responsible for providing a study overview during this meeting.

Please notify the PET Center of all major protocol amendments. These updates are required to ensure proper upkeep of our internal documentation as well as accurate reporting to regulatory agencies (e.g. FDA) and Yale oversight committees (e.g. HIC, RIDC/RDRC, and YU RSC). If imaging procedures are impacted, an additional kick-off meeting may be required prior to amendment implementation.

Scheduling:

• Scan Requests: All scheduling requests and questions must go through pet.scheduling@yale.edu only. This includes every scan request and change request. Please do not call or send emails to individual staff in the PET Center, as this will result in delayed receipt and processing of the request.
• PET Scan Dates: Scan dates are provided approximately 4-6 weeks in advance. If you are unable to use a scheduled PET scan date, contact pet.scheduling@yale.edu to cancel and request a new scan date. This should be done as soon as possible to avoid cancellation fees.

Important:

• Do not delegate your scan date to another PI. The PET Center will reassign canceled slots based upon the current pending scan requests. When you cancel a scan slot, you may offer replacement recommendations, if you are aware of another PI seeking a slot.
• If a subject is identified after a slot is cancelled, please contact pet.scheduling@yale.edu to re-schedule.

PET Scan Times:

• TENTATIVE arrival and injection times will be provided 14 calendar days in advance. Please be aware these times are subject to change.

• OFFICIAL (confirmed) arrival and injection times will be provided 7 calendar days in advance.
• For outside/purchased doses (e.g. [¹⁸F]FDG), times are provided one month in advance.
• Please note that times may change on the PET scan day, due to unforeseen circumstances. We recommend that subject availability is confirmed for the full scan day (~7am-5pm), to ensure scans may proceed in the event of delays. (Refer to section 3B for delayed scan policy)

Subject Information:

• Subject information is to be provided to the PET Center no later than 3 business days prior to the scheduled scan.
• If subject information is not received by this deadline, a $100 fee will be charged.
• Failure to provide subject information, or failure to respond to requests for information, may result in the slot being canceled. In this case, a late cancellation fee will be applied.

Cancellations/Scan Changes:

Cancellations: The following fee structure will be used for cancelled PET scan slots:

• No cancellation fee: scans canceled >=14 calendar days prior to the scheduled scan date
• Early cancellation fee (8% of the cost of the scheduled study): scans canceled between 13 and 8 calendar days prior to the scheduled scan date.
• Late cancellation fee (20% of the cost of the scheduled study): scans canceled between 7 and 3 calendar days prior to the scheduled scan date
• A study canceled 2 business days or less prior to the scheduled scan date will incur 100% of the cost of the study.
• Exception: During Yale Recess/Holiday periods, timing will be adjusted to calendar days.
• Day of Scan Cancellation Fees: 100% of the scheduled study cost
• Fee Waivers/Reductions: Cancellation charges may be waived or reduced under certain circumstances. Requests for a fee modification must be sent to pet.scheduling@yale.edu . Please include the study name, date, and cancellation reason. Requests will be approved at the discretion of the PET Center.

Delayed Scans: The PET Center may need to adjust the injection time on the day of scan, due to chemistry/pharmacy or other operational delays.

• A late cancellation fee will be f the delay is less than 2 hours, and the subject declines the scan.
• If the delay exceeds 2 hours, and the subject declines the scan, a fee will not be charged.
• Note: Please ensure subjects are informed that delays are possible and they may be asked to remain at the PET Center longer than initially estimated.

Rescheduled Scans: The PET Center may reschedule your scan, if an urgent need arises. In these cases, vulnerable or sensitive populations may supersede scans such as healthy controls.

Change Requests:

• Radiotracer change requests
• All radiotracer change requests must be received no later than 8 business days before the scheduled scan.
• Changes received after this deadline, which are still able to be accommodated, will incur a tracer conversion fee of $500.
• For outside/purchased doses (e.g. [¹⁸F]FDG), change requests must be received within 3 business days. Change requests that are received/implemented after this time will incur a tracer conversion fee of $500.
• Procedures Change requests
• Requests to add a procedure (e.g. add drug dosing, arterial line, medical coverage, or increase scan length) must be received no later than 4 business days before the scheduled scan, to ensure adequate staff coverage.
• Changes received after this deadline that are still able to be accommodated will incur a procedure change fee of $125.
• Subject Change requests
• Subject changes must be made no later than 12PM 1 business day before the scheduled scan.
• If a change request is received after 12PM for scans occurring the next day, the PET Center may cancel your scan slot, and a late cancellation fee will be applied.
• For scans that are scheduled on Monday, changes will need to be made no later than 12PM Friday. If there happens to be a holiday before a scan, the changes will also need to be done 1 business day before the scheduled scan.
• Participant changes cannot be completed on the day of the PET scan.

Please note that late change requests require additional time/resources to confirm feasibility, adequate staff, and update files. The PET Center aims to accommodate requests wherever possible.

Scan Day Requirements

• Coordinator Coverage: All subjects must be accompanied to the PET Center imaging floor by a study coordinator.
• The coordinator must stay onsite until the research subject has been injected with radiotracer.
• Once scanning has begun, the coordinator may leave the area if they are reachable for urgent issues. Coordinators are required to verify their contact information is on file, and return 15 minutes prior to the end of the PET scan, in order be onsite for subject discharge.
• For some vulnerable populations, a coordinator may need to stay onsite throughout the scan day.
• PET Center Access: All study personnel must leave with their subject at discharge. This is the end of the scan day and concludes access to the PET Center. Additional time/space is only permitted if required in order to comply with the protocol procedures and if requested/approved in advance.
• Physical Exam and/or EKG: If a recent physical exam or EKG is not available and cannot be obtained prior to the PET scan day, please contact the PET Center to schedule these procedures. The cost for these additional procedures are $250 for the physical exam and $100 for the EKG.
• Early Arrivals: Research subjects, and non-PET Center research staff, are not permitted to be on the imaging floor without PET Center medical personnel. If you arrive early, do not attempt to enter the imaging floor. You and your participant must wait to be checked-in by nursing staff or other medical personnel.
• Late Arrivals: If your subject is running behind schedule, please contact the PET Center Nursing Staff at: (203) 491-8438

With our staff of APRNs, RNs, NMTs, and MDs, we offer a full spectrum of clinical services for PET research inside and outside the medical school for projects enrolling human subjects.

• Review all protocols
• Coordinate clinical resources internally and externally
• Develop study-specific procedures
• Provide clinical training to staff.

• RAs ensure proper subject selection for individual protocols with medical coverage, care, guidance, and consultation.
• Screenings with physical examination and medical clearance
• Coverage/supervision of PET scans of over 50 different radioligands
• Inpatient hospitalization and monitoring through the Clinical Research Unit at YNHH and the Clinical Neuroscience Research Unit at CMHC
• Medical administration and supervision of pharmacologically active compounds

Our subject population is diverse, including cancer patients undergoing chemotherapy treatment, individuals with psychiatric conditions, and patients with neurological disorders such as Parkinson’s disease, epilepsy, and multiple system atrophy. Clinical research at the Yale Biomedical Imaging Institute adheres to Good Clinical Practices (GCP) in all human studies.

PET Center FY25 prices for the above-referenced period are as follows:

Note that it is very important to provide charging instructions in advance of the first scan.

Please refer questions on PET pricing to Maribel Rayas.

• Early cancellation (13 calendar days prior to study): 8% of scheduled study
• Late cancellation (7 calendar days prior to study): 20% of scheduled study
• 48 hours or less prior to study: 100% of full cost of study

• Late Subject Information: $100
• Late Tracer Conversion: $500
• Late Notice of Procedure Changes: $125

Please refer to the Imaging Study Policy for a detailed explanation of the cancellation policy and other fees.

Please refer any questions regarding clinical trial Fund 29 (FD29) budgeting to Shannan Henry.

Non-profit: Please see our FY25 External Non-Profit Price List.

Please refer questions on PET pricing to Maribel Rayas.