Technetium Tc 99m Albumin (Systemic)


VA CLASSIFICATION
Primary: DX201

Commonly used brand name(s): Frosstimage Albumin; Technetium Tc 99m HSA.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Diagnostic aid, radioactive (cardiac disease)—

Indications

Accepted

Cardiac blood pool imaging, radionuclide—Technetium Tc 99m albumin by intravenous administration is indicated as a cardiac blood pool imaging agent and as an adjunct in the diagnosis of pericardial effusion and ventricular aneurysm. {01} {05} {06}
—Although technetium Tc 99m albumin is an acceptable agent for cardiac blood pool imaging, it is not as widely used as technetium Tc 99m–labeled red blood cells for this indication. {08} {14}

Unaccepted
Technetium Tc 99m albumin has been used in placenta localization and may be used in blood volume determinations. However, for placenta localization, it has generally been replaced by the ultrasound technique. In general, blood volume determinations are performed with Cr 51– or technetium Tc 99m–labeled red blood cells (RBC) for RBC volume determinations, and with radioiodinated serum albumin for plasma volume determinations. {03} {06}

Technetium Tc 99m albumin has been used in lymphoscintigraphy to evaluate lymphatic drainage patterns of malignant melanoma. {14} {15} {16} {17}


Physical Properties

Nuclear data:



Radionuclide
(half-life)
Decay
constant
Mode
of
decay
Principal
photon
emissions
(keV)
Mean
number of
emissions/
disintegration
(³0.01)
Tc 99m
(6 h)
0.1151 h -1
Isomeric
transition to
Tc 99
Gamma
(18)
0.062
Gamma
(140.5)
0.891


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Human albumin occurs naturally as the major protein component of blood. When labeled with technetium Tc 99m and given intravenously, it is distributed throughout the body in much the same way as the patient's serum albumin, and serves as a suitable tracer with which to transiently image the vascular compartment. {08} {14}

Distribution:

Vascular system; no significant accumulation in organs, except the kidneys, liver, and bladder. {01} {03} {08} {10}

Half-life:

Biological (normal human serum albumin)—Elimination: 10 to 16 hours. {11}

Radiation dosimetry:
{07}

Estimated absorbed radiation dose*
Organ
mGy/MBq
rad/mCi
Heart
0.20
0.74
Spleen
0.14
0.52
Lungs
0.13
0.48
Bone surfaces
0.0089
0.033
Adrenals
0.0083
0.031
Kidneys
0.0081
0.030
Red marrow
0.0075
0.028
Liver
0.0073
0.027
Pancreas
0.0064
0.024
Stomach wall
0.0051
0.019
Thyroid
0.0049
0.018
Uterus
0.0048
0.018
Small intestine
0.0048
0.018
Large intestine
wall (upper)
0.0047
0.017
Breast
0.0046
0.017
Ovaries
0.0044
0.016
Large intestine
wall (lower)
0.0042
0.016
Bladder wall
0.0040
0.015
Testes
0.0029
0.011
Other tissue
0.0040
0.015
Effective dose: 0.079 mSv/MBq (0.29 rem/mCi)
* For adults; intravenous injection. Data based on the International Commission on Radiological Protection (ICRP) Publication 53—Radiation dose to patients from radiopharmaceuticals. {07}

Elimination:
    Renal, about 39% eliminated within 24 hours. {05} {11}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to human albumin products may be sensitive to this product also. {11}

Pregnancy/Reproduction

Pregnancy—
Tc 99m (as free pertechnetate) crosses the placenta. However, studies have not been done with technetium Tc 99m albumin in humans.

The possibility of pregnancy should be assessed in women of child-bearing potential. Clinical situations exist where the benefit to the patient and fetus, based on information derived from radiopharmaceutical use, outweighs the risks from fetal exposure to radiation. In these situations, the physician should use discretion and reduce the radiopharmaceutical dose to the lowest possible amount. {12}

Studies have not been done in animals.

FDA Pregnancy Category C. {05}

Breast-feeding

Although it is not known whether technetium Tc 99m albumin is excreted in breast milk, it is known that Tc 99m as free pertechnetate is excreted in breast milk. Based on the assumption that the Tc 99m in breast milk is in the form of pertechnetate and based on the effective half-life of the radionuclide in breast milk, the daily volume of milk, a dose factor relating the radionuclide to its critical organ (thyroid) in the nursing infant, and the maximum permissible dose to that organ, a guideline has been proposed. According to this guideline, it has been calculated that nursing can be safely resumed when the concentration in breast milk reaches 30.3 × 10 -4 megabecquerels (8.2 × 10 -2 microcuries) per mL. This level of activity is probably reached, in the majority of patients, within 24 hours after administration of technetium Tc 99m–labeled radiopharmaceuticals. {02} {03}

Pediatrics

There have been no specific studies evaluating the safety and efficacy of technetium Tc 99m albumin in children. When this radiopharmaceutical is used in children, the diagnostic benefit should be judged to outweigh the potential risk of radiation. {13}


Geriatrics


Appropriate studies on the relationship of age to the effects of technetium Tc 99m albumin have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date. {03}

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit must be considered when the following medical problem exists
Sensitivity to human albumin products or to the radiopharmaceutical preparation


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent
    
Allergic reaction (shortness of breath; skin rash)
{04}{11}




Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Radiopharmaceuticals (Diagnostic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Action in the body: Distribution in body of injected radioactive albumin

Visualization of radioactivity in blood pool

Small amounts of radioactivity used in diagnosis; radiation received is low and considered safe

Before having this test
»   Conditions affecting use, especially:
Sensitivity to albumin products or to the radiopharmaceutical preparation

Pregnancy—Technetium Tc 99m (as free pertechnetate) crosses placenta; risk to fetus from radiation exposure as opposed to benefit derived from use should be considered





Breast-feeding—Not known if technetium Tc 99m albumin is excreted in breast milk, but Tc 99m as free pertechnetate is excreted in breast milk; temporary discontinuation of nursing may be recommended because of risk to infant from radiation exposure





Use in children—Risk from radiation exposure as opposed to benefit derived from use should be considered


Preparation for this test
Special preparatory instructions may be given; patient should inquire in advance

Precautions after having this test
No special precautions


Side/adverse effects
Signs of potential side effects, especially allergic reaction


General Dosing Information
Radiopharmaceuticals are to be administered only by or under the supervision of physicians who have had extensive training in the safe use and handling of radioactive materials and who are authorized by the Nuclear Regulatory Commission (NRC) or the appropriate Agreement State agency, if required, or, outside the U.S., the appropriate authority.

Epinephrine, antihistamines, and corticosteroid agents should be available during the administration of technetium Tc 99m albumin because of the possibility of allergic reactions.

Manufacturer's package insert or other appropriate literature should be consulted for optimal times when imaging should be performed.

Safety considerations for handling this radiopharmaceutical
Improper handling of this radiopharmaceutical may cause radioactive contamination. Guidelines for handling radioactive material have been prepared by scientific, professional, state, federal, and international bodies and are available to the specially qualified and authorized users who have access to radiopharmaceuticals. {18}


Parenteral Dosage Forms

TECHNETIUM Tc 99m ALBUMIN INJECTION USP

Usual adult administered activity
Cardiac blood pool imaging
Intravenous, 111 to 185 megabecquerels (3 to 5 millicuries). {05} {06}


Usual pediatric administered activity
Safety and efficacy have not been established in children under 18 years of age. {05} {11}

Usual geriatric administered activity
See Usual adult administered activity .

Strength(s) usually available
U.S.—



Reaction vial:


7 mg of albumin human and 80 mcg (0.08 mg) of stannous tartrate (lyophilized mixture, under nitrogen atmosphere), per 5-mL unit dose vial (Rx) [Technetium Tc 99m HSA]


21 mg of albumin human and 230 mcg (0.23 mg) of stannous tartrate (lyophilized mixture, under nitrogen atmosphere), per 10-mL multidose vial (Rx) [Technetium Tc 99m HSA]

Canada—


Reaction vial: 50 mg of albumin human, 200 mcg (0.2 mg) of stannous chloride dihydrate, and 2 mg potassium biphthalate (lyophilized mixture, under nitrogen atmosphere) (Rx) [Frosstimage Albumin]

Packaging and storage:
Before and after reconstitution—Store between 2 and 8 °C (36 and 46 °F). Protect from freezing. {05}

Preparation of dosage form:
To prepare injection, an oxidant-free sodium pertechnetate Tc 99m solution is used. See manufacturer's package insert for instructions.

Stability:
Injection should be administered within 6 {01} {03} hours after preparation.

Incompatibilities:
If oxidants such as peroxides and hypochlorites are present in the sodium pertechnetate Tc 99m used for labeling, the final preparation may be adversely affected and should be discarded.

Note: Caution—Radioactive material.




Revised: 08/02/1994



References

Note: All references used in the development and earlier revisions of this monograph have not yet been incorporated into the computer database and, therefore, are not listed below. Citations for information not yet referenced in the monograph will be provided upon request.

  1. Package insert (Medi-Physics), Rev 7/87; Rev 11/88.
  1. Romney, et al. International Commission on Radiological Protection. Annals of the ICRP. ICRP Publication 53—Radiation dose to patients from radiopharmaceuticals. New York: Pergamon Press, 1988: 173.
  1. Panel/panelist comments.
  1. European Association of Nuclear Medicine News. Eur J Nucl Med 1992; 19: A11-A12.
  1. Package insert (Medi-Physics—US), Rev 2/91.
  1. Package insert.
  1. Task Group of Committee 2 of the International Commission on Radiological Protection. Annals of the ICRP. ICRP Publication 53—Radiation dose to patients from radiopharmaceuticals. New York: Pergamon Press, 1968: 173.
  1. Swanson DP, Chilton HM, Thrall JH, editors. Pharmaceuticals in medical imaging. New York. Macmillan Publishing Company, 1990: 448-9.
  1. NCRP #70.
  1. JNM 1978 19: 796.
  1. Package insert (Medi-Physics), Rev 6/89.
  1. Radiopharmaceutical Advisory Panel meeting of 5/08/91.
  1. Radiopharmaceutical Advisory Panel meeting of 8/04/92.
  1. Reviewers' comments as of 08/19/92 revision.
  1. Ohtake E, Matsui K. Lymphoscintigraphy in patients with lymphedema. A new approach using intradermal injections of technetium-99m human serum albumin. Clin Nucl Med 1986; 11(7): 474-8.
  1. Ohtake E. Dynamic lymphoscintigraphy with Tc 99m human serum albumin. Radiat Med 1983; 1(2): 132-6.
  1. Lamk LM, Haynie TP, Balch CM, et al. Lymphoscintigraphy in the surgical management of patients with truncal melanoma: comparison of Tc 99m sulfur colloid with Tc 99m human serum albumin. J Nucl Med 1989; 30: 844.
  1. Reviewers' responses to Ballot of 5/11/94.
  1. Atkins HL, Klopper JF, Ansari AN, et al. A comparison of Tc 99m–labeled human serum albumin and in vitro labeled red blood cells for blood pool studies. Clin Nucl Med 1980; 5: 166-9.
  1. Thrall JH, Freitas JE, Swanson D, et al. Clinical comparison of cardiac blood pool visualization with technetium 99m red blood cells labeled in vivo and with technetium 99m human serum albumin. J Nucl Med 1978; 19: 796-803.
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