Case Studies

Case Study 1

Melanoma, Left Upper Arm: 65 Year-Old Male*

Patient Data

  • Pre-operative diagnosis
    • Melanoma, Clark Level IV, posterior aspect of the L upper arm
  • Tc 99m tilmanocept dosing
    • 4 intradermal injections at 12, 3, 6, and 9 o’clock positions (4 TB syringes x .25mL per syringe)
    • Total radioactive dose 0.50mCi
  • Preoperative lymphoscintigraphy
    • Planar images acquired for a total of 90-120 seconds each; three anterior and one lateral with and without Co-57 transmission source
    • A single lymph node visualized in the mid L axilla within 15 minutes post injection
  • Intra-operative findings: single sentinel lymph node identified within mid L axilla
  • Node was pathology negative

Images

Static Planar Images: Obtained for a total of 90-120 sec each

 

*Images and patient data provided courtesy of Nicholas Wickersham, MD and Elizabeth Beltran, CNMT, Boulder Community Health, Boulder, CO, USA

Case Study 2

Melanoma, Left Mid-Back: 51 Year-Old Male*

Patient Data

  • Pre-operative diagnosis
    • Malignant melanoma 1cm left of the midline at the level of T12-L1, Breslow thickness of 0.6mm with no ulcerations
  • Tc 99m tilmanocept dosing
    • 4 intradermal injections at 12, 3, 6, and 9 o’clock positions (4 insulin syringes x 0.1mL per syringe)
    • Total radioactive dose 0.5mCi
    • No use of blue dye or local anesthetics
  • Pre-operative lymphoscintigraphy
    • Planar posterior dynamic images (30 sec/frame for 5 minutes)
    • Static planar spot images (180 sec/image) were acquired
    • SPECT was performed with low dose CT for attenuation correction of the SPECT data and limited anatomic correlation
      • CT – acquired first for 4 minutes. 256 matrix, 140keV@ 2.5mA, pitch 1.9, 4.42mm intervals.
      • SPECT – acquired for 15 minutes. 64 matrix, 30 frames, 30 sec/frame, 360 degrees.
    • Sentinel lymph nodes were identified and marked on the skin surface under imaging guidance.
    • Impression:
      • Two adjacent left axillary sentinel lymph nodes are identified. These were marked on the skin surface under imaging guidance with a single mark.
      • Three foci of radiotracer accumulation are identified in the right axilla. The more inferior 2 foci are consistent with sentinel lymph nodes and were marked on the skin surface under imaging guidance. The most superior or cranial focus is also the faintest focus. This is questionable for sentinel lymph node and was also marked on the skin surface under imaging guidance.
      • No inguinal lymphatic drainage was identified.
  • Intra-operative findings
    • Right axilla:
      • Sentinel lymph node #1 in vivo count 4221, ex vivo 7806
      • Sentinel lymph node #2 in vivo count 5528, ex vivo 8515
    • Left axilla:
      • Sentinel lymph node #1 in vivo count 23083, ex vivo 23793
      • Sentinel lymph node #2 in vivo count 5119, ex vivo 5227
      • Sentinel lymph node #3 ex vivo count 1425
  • Pathology findings
    • Right axilla:
      • Sentinel lymph node #1 - negative
      • Sentinel lymph node #2 - positive for micrometastasis
    • Left axilla:
      • Sentinel lymph node #1 - positive for micrometastasis
      • Sentinel lymph node #2 – negative
      • Sentinel lymph node #3 – negative
    • Micrometastatic melanoma is present as rare single cells in the subcapsular area of two sentinel lymph nodes. The largest metastatic focus is composed of no more than half a dozen cells present over a little less than 1 mm in length. The metastatic disease is identified by immunostains.

Images

Static Planar Images: Obtained for a total of 90-120 sec each

*Images and patient data provided courtesy of Stanley Leong, MD , Max Wu, MD and Donald Torre, CNMT, Sutter Health California Pacific Medical Center, San Francisco, CA, USA

Case Study 3

Invasive Lobular Carcinoma, L Breast: 77 Year-Old Female*

Patient Data

  • Tc 99m tilmanocept dosing:
    • 1 intradermal injection – peri-areolar in the upper outer quadrant of the left breast (one 1mL TB syringe, with 0.2mL total volume)
    • Total radioactive dose 0.51mCi, no local anesthetic used
    • Blue dye not used
  • Preoperative lymphoscintigraphy
    • Static planar images; anterior, L anterior oblique, and L lateral positions; 5 minutes per image
    • Two L axillary lymph nodes visualized within 30 minutes post injection
  • Intra-operative findings: 2 sentinel nodes identified within L axilla; nodes removed (ex-vivo count rates of 2900 cps and 350 cps)
  • Both axillary nodes were pathology negative

Images

Static Planar Images: 5 min/image

Anterior
L Anterior Oblique
L Lateral
 

*Images and patient data provided courtesy of Ray Kiendl, Executive Director of Radiology, Elkhart General Hospital, Elkhart, IN,USA


*Indication

LYMPHOSEEK is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

  • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
  • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

 

Important Safety Information

In clinical trials with LYMPHOSEEK, no serious hypersensitivity reactions were reported, however LYMPHOSEEK may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of LYMPHOSEEK, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of LYMPHOSEEK administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).
Please see full Prescribing Information.

To report suspected adverse reactions, contact Cardinal Health at 1.800.618.2768 or FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.

The information on this web site is intended for use only by healthcare professionals in the United States.