Miraluma Test Now an Option for Indeterminate Mammograms

PHOENIX, Ariz—A woman with an indeterminate mammogram is often told to “wait and see what develops,” and to schedule another mammogram in 3 to 6 months. The radiodiagnostic test Miraluma (Kit for the Preparation of Technetium Tc99m Sestamibi) offers a noninvasive second step to women who might otherwise have to “wait and see,” Hirsch Handmaker, MD, said in an interview.

Dr. Handmaker, a specialist in nuclear medicine in the Phoenix area and president of Healthcare Technology Group, a firm involved in research, education, and consulting, participated in the clinical trials of Miraluma that led to its approval earlier this year. “Women appreciate having another option after an abnormal mammogram,” he said.

In his experience, the most common use of Miraluma is in the woman with an indeterminate mammogram, usually a younger woman who has dense or fibrocystic breasts that make it difficult to feel a new or different mass in the breast and difficult to get an accurate mammogram.

These patients generally fall into two categories, Dr. Handmaker said, and both are candidates for Miraluma as an adjunct to mammography. First is the patient who has a routine mammogram that is not clearly normal and no palpable lesion. Rather than waiting several months for a second mammogram, Miraluma might be recommended, particularly if the woman has risk factors for breast cancer, such as a family history of the disease or a previous breast cancer herself.

Second is the woman who feels a lump but whose mammogram is equivocal or indeterminate, especially if she is reluctant to have a biopsy.

In one unusual case in Dr. Handmaker’s experience, a woman with an abnormal mammogram who was reluctant to undergo biopsy was convinced to do so by a positive Miraluma study .

A Tale of Four Biopsies

In 10 years, Edith Esposito had three abnormal mammograms of her left breast and three biopsies. The first biopsy showed atypical cells that were not malignant and the second and third showed scar tissue.

“It really disturbed me that, in today’s advanced age, they were unable to tell scar tissue from a malignant lesion,” she said. Undergoing the biopsies was not only invasive and painful but also frustrating, and, she said, “I began to lose confidence in the procedure as a whole.”

Then Edith had a fourth abnormal mammogram, this time in her right breast. Based on her last three experiences, she refused a biopsy, feeling confident it was simply another mistake, and that a biopsy would result in more scar tissue. But her physician called Dr. Handmaker who encouraged her to join the clinical trial of a new noninvasive diagnostic test.

Edith’s Miraluma test was positive, and she had her biopsy, followed by breast-conserving surgery for a malignant lesion. “Without the Miraluma test,” she said, “I would have waited several months to see if the lesion changed.”

The cost of Miraluma testing can run up to $600, although Dr. Handmaker believes that the price should be more in the range of $350 to $400. He said he was encouraged to see that Blue Cross, Blue Shield of Arizona quickly authorized payment for the test in one of his patients, especially since many insurers often follow the Blues’ lead.

In Arizona, he said, “medicine is intensively managed,” and reimbursement for Miraluma testing must be dealt with on a case by case basis. “When the indication is clear and the referring physician has said that Miraluma testing will make a management difference, most companies have been paying,” he said. “If we take the time to talk to someone in the organization who understands why the test is being done, we’re more likely to get approval.”