(Fwd) Re: Lymphoscintigraphy

["Pete Myers" <Pete.Myers@tdh.state.tx.us>]

[Thought this might be of general interest ... ] 

Scintilymphography (or lymphoscintigraphy) is a technique becoming 
popular in localizing "sentinel" lymph nodes, the first node(s)
draining the primary tumor in patients with invasive breast cancer.  

         [The procedure is more well established in 
           determining the spread of melanomas.]

The purpose for the breast study is to identify lymph nodes to which 
cancerous cells have migrated and, then, excise only those nodes.

The study involves the ultra-sound guided injection of 0.5-2.0
mCi of Tc-99m Sulfur Colloid (SC) in the area of a known tumor.
Although the intra-dermal injection of Tc-99m SC for the purpose
of performing scintilympography is not an "FDA-approved" use of
the drug (i.e., is not included on the package insert), we, in
Texas, have recently considered off-label uses to be within the
"practice of medicine" and, therefore, a study which can be
ordered by an appropriately licensed physician.  We are, therefore,
not requiring that this study be performed under the auspices of a 
RAM License of Broad Authorization or oversight by an FDA-sanctioned
Institutional Review Board (IRB).

We consider scintilymphography to be a Group II (localization)
nuclear medicine study, to be ordered and supervised by a
physician designated as an Authorized Physician User (Group II)
on the facility's radioactive material license.

The injection may be done in the Radiology Department followed by
imaging 30-60 minutes later.  Several companies are marketing hand-
held probes to be passed over the surface of the body, to identify 
those nodes involved with the cancer.  The patient will eventually
be taken to a Surgical Suite where the Surgeon will more precisely
localize the sentinel nodes and excise them.

Because (1) the activity per study is low and the half-life is short, 
(2) persons performing the study use procedures that minimize expo-
sure to biohazardous material and (3) the excised tissue will be
collected and disposed of in a controlled manner, we believe that 
neither the Surgeon nor the OR staff need to be badged; and that
the OR needn't be designated a controlled area.

Bottom line is that the procedure, which involves the use of 
licenseable quantities of radioactive material, must be ordered and 
overseen by an Authorized Physician User, in a team approach with
the Surgeon.

Pete.

PS Please call your regulatory agency for restrictions which may
apply to your licensed activity.

Date:          Tue, 3 Feb 1998 13:50:34 -0600 (CST)
Reply-to:      radsafe@romulus.ehs.uiuc.edu
From:          "Price, Carol J" <PriceCarolJ@exchange.uams.edu>
To:            Multiple recipients of list <radsafe@romulus.ehs.uiuc.edu>

This question is for the medical RSO's.  Has any one in your facility
been involved in a study where a small amount of Tc-99m is injected
around a tumor site and the patient is then sent to the OR.  In the OR
the injection site is scanned with a fine beam  gamma probe and the
primary lymph nodes determined.  My question is this:  Do you treat this
as any other Nuclear Medicine procedure or do you handle it differently?

Please respond to me direct:
PriceCarolJ@exchange.uams.edu

Pete Myers, Cf, Med & Acad Licensing
Bureau Rad Control, Texas Dept Hlth
Phone (512) 834-6688 (FAX 834-6690)
Pete.Myers@tdh.state.tx.us