ACRIN 6666 Follow-Up

1. ACRIN 6666 Follow-Up • 0 month • “12 month” = 11-14 months • If patient has been contacted, plans follow-up, please hold IA, IS, and F1 until she returns (even if > 14 mo) • If patient unable to be contacted (even via referring MD), file IA, IS, F1 by end of 14 mo • If patient returns prior to 22 months, file “revised” 12 month IA, IS

2. ACRIN 6666 Follow-Up • If first follow-up visit is after 22 full months, then = “24 month” visit • Visit prior to 11 months after entry = “off-study” event, IM

3. Following an Off-Study or 6-month Follow-Up Visit • If all study breasts had both mammogram and whole-breast US performed, recommendation may be for “12 month” follow-up, which may not fall at a study time point • If the next “routine visit” = 11 mo < x < 22 months, then = “12 month” visit • If next “routine” visit is ≥ 22 months since study entry, then = “24 month” visit

4. Following Off-Study Event • If only one breast evaluated, ± targeted US performed, then next “annual” should follow on schedule • Patient may refuse mammogram if < 4 months, then IA → not performed

5. “24 month” • ≥ 22 months since study entry • Even if quite late (as long as study open), we are still interested in the data • Due when it has been 11-14 months after the “12 month” exam (though calendar may be off due to intervening events or delay in 12 month exam)

6. 36 months • Ideally wait full 36 months from study entry • Only F1 required

7. ACRIN 6666: MR Component Wendie A. Berg, MD, PhD, FACR Johns Hopkins Green Spring wendieberg@hotmail.com

8. Site Status • Open • ARS, Sunnybrook • Waiting for MR test set of images • UTSW, RIA, UNC (otherwise ready) • USC, MD Anderson (also IRB) • Waiting on investigators and (2nd set) images • Cincinnati • Waiting on investigators, images, IRB • Allegheny • NWU (audit 11/06) • Radiology Consultants (12/06), UCLA (2/07)

9. MR Images • 1.5T scanner • Axial or sagittal T1 and T2FS or STIR bilaterally • 3D volume within 3 minutes of both breasts, ≤ 3 mm slice thickness (≤ 1 mm x ≤ 1 mm in-plane resolution) post Gd • Test set needs approval by Dr. Ed Hendrick (via ACRIN)

10. MR Survey • Detailing technical parameters, scan timing, sent to sites 9/24/06 • Kudos to: ARS, Sunnybrook, USC, UNC, RIA, UCLA, Radiology Consultants • Missing from: Allegheny, UTSW, Cincinnati, MD Anderson, NWU

11. Problems with MR images to date • Timing post injection: DICOM headers not always correct or include pre-scan • At least 6 minutes total after injection, no delays • Resolution, slice thickness issues • MIP and subtraction images • If done on separate workstation or using CAD software, may not come over as part of the original image set, may need to be sent separately

12. Sending MR images to ACRIN • Sample set from non-study patient renamed (using preview software): Use site # and send to ACRIN • Provide contact information for lead MR tech: work out problems with Dr. Hendrick • Another set of images will likely need to be sent

13. Recruiting Participants • Still eligible for main study • No current clinical symptoms • No metastatic disease • No MRI of any study breast(s) within past 12 months, no screening MRI within past 24 months • No surgery in prior 12 months ± CNB prior 5 months

14. Recruiting MR Participants • Send patient information letter in advance of 24 month visit • Schedule MRI at same visit as 24 month US, mammo • Days 7-14 after onset of menses if premenopausal • In no case longer than 4 weeks (28 days) after

15. Recruiting MR participants • If patient is uninsured or underinsured (e.g. large deductible), limited funds have been set aside at ACRIN • Request approval from ACRIN in advance • Patient may want to check with her insurance in advance, verify her deductible

16. A2 • If your site is participating in the MR supplement, you will need to complete an A2 on every 6666 participant from your site • ACRIN will suppress those prior to opening of your site • Patient does not need to sign if refuses • Please provide reason for not participating

17. ARS Johns Hopkins-MR 6666 • 25 eligible participants as of 10/4/06 • 8 prior to study open (8/1/06), 2 had MRI • Of 17 remaining, • 3 (18%) had MRI • 3 (18%) severe claustrophobia • 5 (29%) not interested • 3 (18%) cannot take the time • 1 (6%) each: “hates needles”, “health issues”, “not high risk per my doctor” (with h/o DCIS in 40’s)

18. Referring MDs • Requires communication with referring physicians as to goals of study, need to encourage participation • Referral often required by insurance

19. MR of Study Participants • Interpret blinded to the 24-month US and mammogram • If necessary the mammo interpreting physician can read the MR • Prior to any biopsies prompted by 24-month US and mammogram • M3 form for each breast • Integration interpretation if other than routine follow-up, separate paragraph in clinical report • MX (not yet online)

20. Additional Work-Up from MRI • Revisions to BX, IM are in progress • Please indicate MRI prompted work-up in comments (by lesion #)