123I-N-（2-二乙氨基乙基）-2-碘苯甲酰胺用于原发性和转移性眼黑色素瘤诊断的二期临床研究

[Phase 2 clinical study of 123I-N-(2-diethylaminoethyl)-2-iodobenzamide in the diagnostic of primary and metastatic ocular melanoma].

作者信息

Sillaire-Houtmann I, Bonafous J, Veyre A, Mestas D, D'Incan M, Moins N, Kemeny J-L, Chossat F, Bacin F

机构信息

Service d'Ophtalmologie, CHU, Hôpital Gabriel Montpied, Clermont-Ferrand.

出版信息

J Fr Ophtalmol. 2004 Jan;27(1):34-9. doi: 10.1016/s0181-5512(04)96089-5.

DOI:10.1016/s0181-5512(04)96089-5

PMID:14968075

Abstract

PURPOSE

Iodobenzamides are reported to possess an affinity for melanoma. A first selected compound, BZA, was studied in a phase 2 clinical trial on 159 patients as an imaging agent for the detection of primary melanoma and metastases with good results. We report the results of a second phase 2 clinical trial on 40 patients with a new radiopharmaceutical BZA2 (an orthoiodinated BZA analog), which was expected to provide quality images sooner after injection and with better imaging contrast.

PATIENTS AND METHODS

Performance was evaluated in 40 patients classified with primary ocular lesions (12), suspicion of metastases of ocular or cutaneous origin (15), or with no known secondary lesion (13), and results were compared with conventional investigation techniques (ophthalmoscopy, ultrasonography, and angiography for ocular melanoma, whole-body CT scan and ultrasonography for metastases).

RESULTS

No adverse events were recorded. The overall results on a per patient basis showed a sensitivity of 78% and a specificity of 95%. The four false negatives observed were ocular lesions (three with a thickness<3mm and one achromic), but all the proven secondary lesions were imaged. Moreover, negative BZA2 scintigraphy in cases of suspicious lesions led to the correction of two diagnoses: the prostatic origin of bone metastases and the endocrine tumor origin (APUD system) of an ocular lesion.

DISCUSSION

BZA2 scintigraphy is an easy test with good tolerance. In the diagnosis of ocular primary melanoma, the sensitivity of the test is 64%, although limited by the thickness (3mm) and the pigmentation of the lesion. However, the BZA2 scintigraphy is a very useful test for the detection of melanoma metastases, with a sensitivity of 100% and a specificity of 95%.

CONCLUSION

BZA2 scintigraphy showed good tolerance in patients and it appears promising for differential diagnosis, staging, and restaging of melanoma.

摘要

目的

据报道，碘苯甲酰胺对黑色素瘤具有亲和力。第一种选定的化合物BZA，在一项针对159名患者的2期临床试验中作为检测原发性黑色素瘤和转移灶的成像剂进行了研究，结果良好。我们报告了一项针对40名患者的第二项2期临床试验的结果，该试验使用了一种新的放射性药物BZA2（一种邻碘BZA类似物），预计该药物在注射后能更快地提供高质量图像，且成像对比度更好。