January 18 2023
Written by Pamela J. Mason, RN, BSN, CCRP, and Julie Williams, PhD, MPH, Clinical Trials Coordinators at FirstHealth of the Carolinas.
We are coordinators in a large community-based hospital system in North Carolina. The information shared here is a culmination of our experiences with RECIST tracking and the tool we utilize to accomplish this task. We offer this guidance to set you up for success. We realize every site is different so some of the information may not apply to your specific situation.
Utilize the same reading radiologist or core group of radiologists
Our site has about 20 reading radiologists. It’s optimal to have dedicated staff or at least a core group to read for consistency. Depending on your site’s situation, this may or may not be possible.
Screening Scan – Standard of Care (SOC) vs. Study Specific
Always refer to the protocol and any notes/trainings such as Site Initiation Training (SIV) if applicable, presentations for study specific guidelines regarding the allowed timing for SOC imaging that may have already been performed and if this is acceptable to use for the baseline/screening requirement. If the scan was SOC, please have the radiologist read the scan to obtain measurements on all identified lesions. Remember to save correspondence of the identified lesions as a source document.
Know your protocol
Refer to the protocol to determine how lesions will be identified and followed. While many protocols use RECIST 1.1, immunotherapy based trials sometimes use irRECIST. Immune related Response Criteria (irRECIST) takes into account the additional time often needed to demonstrate response using immunotherapy treatments. There are a few differences between the two methods so be sure to know what the protocol uses prior to enrolling.
Identify Baseline lesions
Review lesions with the treating physician and include the lesions on a tracking tool for comparison at subsequent time points. If the treating physician is unsure of what lesions should be followed consider asking the PI or Sub for assistance. Try to use the same terminology as the imaging report to describe the lesions on the tracking tool. Remember measurable, reproducible, and representative of overall disease burden! Refer to protocol specific guidelines regarding use of lesions noted with prior radiation, in a surgical field, or areas that have been biopsied. These lesions may be required to be non-target lesions.
Communicate lesion (target and non-target) information to radiologist ahead of time
Take time to understand your facility and workflow. Identify a contact in the imaging department to facilitate your needs. When communicating regarding follow up scans include target lesion information in the order, and send an e-mail prior to the scan to the department contact. Include the location and image slice from previous scans, if known. Request lesions to be measured in 2 dimensions.
Consider scan timing
What works best for the patient within protocol parameters? If the patient is not a “morning person”, ensure that their appointments are scheduled for the afternoon to promote compliance. Scans should occur before provider visits to allow time to analyze and review the results without rushing. Consider a few days prior, avoid the day of the provider visit/ Day 1 of cycle. In some cases, getting scans after the start of a cycle may be preferrable to allow for time to evaluate RECIST response. Remember, scans typically follow set schedule regardless of cycle delay.
Be proactive
Check for scan results and review the results with the treating physician. This may or may not be the primary PI and may not be as familiar or comfortable with this process. Ideally, RECIST trained radiologists will document the bi-dimensional measurements including slice number of all target lesions as well as the presence or absence of the non-target lesions directly within the imaging report. Ask for clarifications or addendums from the radiologist if necessary. If the treating physician has additional questions, contact the radiologist for clarification. EPIC secure chat works well for us.
Patient notification
EMR patient portals release patient results when completed. Consequently, the patient may see their results before the physician or the coordinator. When this occurs, they might call and want to know what it means. Prepare patients and alleviate fears ahead of time. Have a conversation with them, assure them that their care team will be reviewing the scans and that if there is any cause for concern, someone will reach out to them.
Use a tracking tool
Make sure your tracking tool has the protocol information listed. We use an Excel file that completes the basic RECIST calculation for you. However, understanding the calculation is critical. Overall Response: % change= (current Sum of diameters - Baseline Sum of diameters) divided by Baseline sum of diameters times 100. Using this formula, a negative number is a decrease, positive number is an increase in size. Don’t forget to include the nadir. If your patient is having a positive response to treatment the nadir will likely change after each scan. Be sure to remember to change the denominator. Also remember that progressive disease is based on a 20% increase from the nadir and at least a 5mm increase in sum of the diameters. The tracking tool should be reviewed for accuracy and signed off by the treating physician at each assessment for demonstration of continued physician oversight.
Know your resources
Protocol, reference articles1,2, team members, physicians, and staff in other departments. We are all in this together. Ask questions, it’s how we learn!
1New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) European Journal of Cancer 45(2009)228–247.
2RECIST 1.1 – Update and Clarification: From the RECIST Committee European Journal of Cancer 62(2016)132–137.
NRG Online Toolkit:
https://www.nrgoncology.org/Home/News/Post/recist-11-criteria-toolkit-a-resource-for-success-in-clinical-trials-with-solid-tumor-evaluation-requirements