TY - JOUR
T1 - Pilot study of 68Ga-DOTA-F(ab')2-trastuzumab in patients with breast cancer
AU - Beylergil, Volkan
AU - Morris, Patrick G.
AU - Smith-Jones, Peter M.
AU - Modi, Shanu
AU - Solit, David
AU - Hudis, Clifford A.
AU - Lu, Yang
AU - O'Donoghue, Joseph
AU - Lyashchenko, Serge K.
AU - Carrasquillo, Jorge A.
AU - Larson, Steven M.
AU - Akhurst, Timothy J.
PY - 2013/12
Y1 - 2013/12
N2 - OBJECTIVE: Ga-1,4,7,10-Tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA)-F(ab')2-trastuzumab [Ga-DOTA-F(ab')2-trastuzumab] has been developed at our institution as a positron imaging reagent for assessing human epidermal growth factor receptor 2 (HER2) expression status by in-vivo imaging. Initial studies on animals demonstrated promising results in the monitoring of treatment response to heat shock protein 90-targeted drugs that inhibit the client protein HER2. We report here our initial clinical experience in the assessment of the toxicity, pharmacokinetics, biodistribution, and dosimetry profile of Ga-DOTA-F(ab')2-trastuzumab with PET/computed tomography using a mean of 236 MBq/5 mg administered intravenously. MATERIALS AND METHODS: A group of 16 women with breast cancer were enrolled in this study. The one patient who did not receive Ga-DOTA-F(ab')2-trastuzumab was excluded from analysis. Both HER2-negative (n=7) and HER2-positive (n=8) cases were studied. Among the latter, seven had undergone trastuzumab treatment previously and one had not. RESULTS: It was determined that Ga-DOTA-F(ab')2-trastuzumab was well tolerated, with a T of ∼3.6±0.9 h; the critical organ was the kidney, with a mean dose of 0.383 cGy/37 MBq; and tumor targeting was seen in 4/8 patients with HER2-positive disease. CONCLUSION: The reagent is safe, and assessments through additional studies in a better-defined group of patients, using larger administered masses of antibodies, with a better immunoreactive fraction are needed.
AB - OBJECTIVE: Ga-1,4,7,10-Tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA)-F(ab')2-trastuzumab [Ga-DOTA-F(ab')2-trastuzumab] has been developed at our institution as a positron imaging reagent for assessing human epidermal growth factor receptor 2 (HER2) expression status by in-vivo imaging. Initial studies on animals demonstrated promising results in the monitoring of treatment response to heat shock protein 90-targeted drugs that inhibit the client protein HER2. We report here our initial clinical experience in the assessment of the toxicity, pharmacokinetics, biodistribution, and dosimetry profile of Ga-DOTA-F(ab')2-trastuzumab with PET/computed tomography using a mean of 236 MBq/5 mg administered intravenously. MATERIALS AND METHODS: A group of 16 women with breast cancer were enrolled in this study. The one patient who did not receive Ga-DOTA-F(ab')2-trastuzumab was excluded from analysis. Both HER2-negative (n=7) and HER2-positive (n=8) cases were studied. Among the latter, seven had undergone trastuzumab treatment previously and one had not. RESULTS: It was determined that Ga-DOTA-F(ab')2-trastuzumab was well tolerated, with a T of ∼3.6±0.9 h; the critical organ was the kidney, with a mean dose of 0.383 cGy/37 MBq; and tumor targeting was seen in 4/8 patients with HER2-positive disease. CONCLUSION: The reagent is safe, and assessments through additional studies in a better-defined group of patients, using larger administered masses of antibodies, with a better immunoreactive fraction are needed.
KW - F(ab0)2-trastuzumab
KW - Ga
KW - Herceptin
KW - PET/CT
KW - breast cancer
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U2 - 10.1097/MNM.0b013e328365d99b
DO - 10.1097/MNM.0b013e328365d99b
M3 - Article
C2 - 24100444
AN - SCOPUS:84887255974
SN - 0143-3636
VL - 34
SP - 1157
EP - 1165
JO - Nuclear medicine communications
JF - Nuclear medicine communications
IS - 12
ER -