ACRIN 6698 TM CRF COMPLETION INSTRUCTIONS
MRI Technical Assessment Form
The purpose of the TM form is to collect the clinical, diagnostic and radiological data that occur with MRI, axial DCE,
and Pre-contrast axial DWI, DWI retest and T2 images.
NOTE: These form completion guidelines only address certain specific form questions.
Additional form completion instructions can be found in the general form instructions document available on the ACRIN
6698 website. Contact data management for all form related questions/clarifications.
General: Dates are recorded as MM/DD/YYYY. Answer all questions unless otherwise specified to skip to another
question.
1) Clinical trial timepoint – Select the timepoint that the imaging occurred. Please reference the ISPY2 Study Plan
for Treatment.
a. Pre-treatment:
Performed before chemotherapy
b. Early treatment: Performed at the end of week 3
c. Inter-regimen:
Performed at the end of week 12
d. Pre-surgery:
Performed as early as week 23 – 30 depending on the chemotherapy cycle
2) Was MRI performed at this visit?
a. No - Skip over all the form questions and Initial and date the form. Complete PR form Q1 option 2, then
provide the reason for the image–related deviation in Q1b.
b. Yes - proceed to Q3.
3) Date of MRI – provide the date the MRI was initiated and completed.
4) Subject weight (2.2 lbs/kg) – Weigh the subject the day of the scan if there is no documented weight. Provide
the subjects weight in kilograms. If unable to weigh the subject, rely on the subject’s self-reported information. If
unable to obtain the weight by any of these methods then check the unknown box.
a. Example: 70 kg x 2.2 = 154 lbs.
b. Example: 110 lbs. / 2.2 = 50 kg
4a) Source of weight – indicate whether weight was measured the day of the scan or provided by the patient.
5) Was T2 imaging performed?
a. No – skip to Q6 (Was DWI performed) and complete PR form Q1 option 2, and then provide the reason
for the image–related deviation in Q1b.
b. Yes – complete questions 5a and 5b.
5a) T2 series #:
Provide the T2 series number.
5b) T2 start time:
Provide the MRI T2 start time in military time.
6) Was DWI performed?
a. No – skip to Q15 (Was DCE performed) and complete PR form Q1 option 2, and then provide the reason
for the image–related deviation in Q1b.
b. Yes – proceed to Q7
9) DWI start time:
Provide the MRI DWI start time in military time.
9a) DWI series scan duration: Provide the duration of a single DWI series. If there are separate series for various b
values, record the time for each series, not the total time of 3 series combined. This
would be the time for 1 of the 3 acquisitions, so it’s a single series of 3.
6698 TM Completion Instructions v1.0
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April 22, 2013
ACRIN 6698 TM CRF COMPLETION INSTRUCTIONS
MRI Technical Assessment Form
10) Were all b-values performed in a single series?
a. No – complete the table in Q10a.
b. Yes – provide the series number and proceed to Q11.
11) Did the participant consent to a retest DWI – Select “Yes” or “No” as applicable.
11a) Was a retest DWI performed? – Select Yes or No as applicable
a. No – Skip to Q15 and complete a PR form which will be triggered to the calendar.
12) Was T2 weighted retest imaging performed? – Select “Yes” or “No” as applicable.
a. No – Skip to Q13.
b. Yes – provide the series number and start time (Military time).
14) Were all b-values performed in a single series?
a. No – complete the table in Q14a.
b. Yes – provide the series number and proceed to Q15.
15) Was DCI performed?
a. No – skip to Q27 (Any adverse events related to imaging to report for this timepoint?) and complete PR
form Q1 option 2, and then provide the reason for the image–related deviation in Q1b.
b. Yes – proceed to Q16
17) Brand of contrast agent injected? Please provide only one response. If brand is not listed, specify other brand.
17a) Was the contrast administered according to protocol? (dose: 0.1 mm/kg body weight, rate: 2cc/sec, flush:
20cc). If no, complete PR form
23) IV guage: provide number
25) Were post-contrast DCE images acquired in the same series as pre-contrast? If no, list series numbers under
Q25a.
26) Was the duration of each phase between 80-100 seconds? If no, complete 26a and PR form.
27) & 27a) captures AE and SAE data for imaging related AEs ONLY.
6698 TM Completion Instructions v1.0
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April 22, 2013