Details

Autor(en) / Beteiligte

• Cachin, Florent
• Miot-Noirault, Elisabeth
• Gillet, Brigitte
• Isnardi, Vanina
• Labeille, Bruno
• Payoux, Pierre
• Meyer, Nicolas
• Cammilleri, Serge
• Gaudy, Caroline
• Razzouk-Cadet, Micheline
• Lacour, Jean Philippe
• Granel-Brocard, Florence
• Tychyj, Christelle
• Benbouzid, Fathalah
• Grange, Jean Daniel
• Baulieu, Francoise
• Kelly, Antony
• Merlin, Charles
• Mestas, Danielle
• Gachon, Francoise
• Chezal, Jean Michel
• Degoul, Francoise
• D'Incan, Michel

Titel

sigma up 123 member of -BZA2 as a Melanin-Targeted Radiotracer for the Identification of Melanoma Metastases: Results and Perspectives of a Multicenter Phase III Clinical Trial

Ist Teil von

• The Journal of nuclear medicine (1978), 2014-01, Vol.55 (1), p.15-15

Erscheinungsjahr

2014

Link zum Volltext

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• Our group has developed a new radiopharmaceutical, sigma up 123 member of -N-(2-diethylaminoethyl)-2-iodobenzamide ( sigma up 123 member of -BZA2), a benzamide derivative able to bind to melanin pigment in melanoma cells. In a prospective and multicentric phase III clinical study, the value of 18F-FDG PET/CT and sigma up 123 member of -BZA2 scintigraphy was compared for melanoma staging. Patients with a past history of cutaneous or ocular melanoma were included from 8 hospitals. sigma up 18 Theta -FDG imaging was performed according to a standard PET protocol. Whole-body, static planar, and SPECT/CT (if available) images were acquired 4 h after injection of a 2 MBq/kg dose of sigma up 123 member of -BZA2. sigma up 18 Theta -FDG and sigma up 123 member of -BZA2 sensitivity and specificity for the diagnosis of melanoma metastasis were calculated and compared on both a lesion basis and a patient basis. True-positive and true-negative lesion status was determined after 6 mo of clinical follow-up or according to lesion biopsies (if available). Melanin content in biopsies was evaluated with the standard Fontana-Masson silver method and was correlated with sigma up 123 member of -BZA2 uptake. Based on statistical analysis, the number of inclusions was estimated at 186. In all, 87 patients were enrolled from 2008 to 2010. Of these, 45 (52%) had metastases. A total of 338 imaging abnormalities were analyzed; 86 lesions were considered metastases, and 20 of 25 lesion biopsies found melanoma metastases. In a patient-based analysis, the sensitivity of sigma up 18 Theta -FDG for diagnosis of melanoma metastases was higher than that of sigma up 123 member of -BZA2, at 87% and 39%, respectively (P 0.05). For specificity, sigma up 18 Theta -FDG and sigma up 123 member of -BZA2 were not statistically different, at 78% and 94%, respectively. In a lesion-based analysis, the sensitivity of sigma up 18 Theta -FDG was statistically higher than that of sigma up 123 member of -BZA2 (80% vs. 23%, P 0.05). The specificity of sigma up 18 Theta -FDG was lower than that of sigma up 123 member of -BZA2 (54% vs. 86%, P 0.05). According to biopsy analysis, only 9 of 20 metastatic lesions (45%) were pigmented with high melanin content. sigma up 123 member of -BZA2 imaging was positive for 6 of 8 melanin-positive lesions, fairly positive for 3 of 10 melanin-negative lesions, and negative for 7 of 10 melanin-negative lesions. The sensitivity and specificity of sigma up 123 member of -BZA2 for the diagnosis of melanin-positive lesions were 75% and 70%, respectively. Because of a low sigma up 123 member of -BZA2 sensitivity, this clinical trial was prematurely closed after 87 patients had been included. This study confirms the value of sigma up 18 Theta -FDG PET/CT for melanoma staging and strengthens the high accuracy of sigma up 123 member of -BZA2 for diagnosis of melanin-positive metastatic melanoma. Moreover, benzamide derivatives radiolabeled with therapeutic radionuclide may offer a new strategy for the treatment of metastatic melanoma patients harboring melanin-positive metastases.