PHASE-II SCINTIGRAPHIC CLINICAL-TRIAL OF MALIGNANT-MELANOMA AND METASTASES WITH IODINE-123-N-(2-DIETHYLAMINOETHYL 4-IODOBENZAMIDE)

Preclinical studies established [I-125]-N-(2-diethylaminoethyl) 4-iodo benzamide (BZA) as a potential radiopharmaceutical in the management o f patients with malignant melanoma. External detection of both murine and human melanotic melanomas was possible after intravenous injection of I-125-BZA in tumor-bearing mice. This article reports a Phase II c linical trial evaluating I-123-BZA as an imaging agent of primary mela nomas and metastases. A total of 110 patients with a history of melano ma were investigated in two nuclear medicine departments. Subjects wer e imaged from 20 to 24 hr after the intravenous injection of 3.5 mCi ( 1 30 M Bq) of I-123-BZA. After injection, no short-term or long-term s ide effects were noted. Calculated on a lesion-site basis, diagnostic sensitivity was 81%, accuracy was 87% and specificity was 100%. The me lanoma nature of previously occult lesions was confirmed by clinical c riteria and/or additional investigations in follow-up studies. The sci ntigraphies were normal in 44 patients in clinical remission after tre atment of malignant melanoma and in seven patients with nonmelanoma di sease. No false positive results were observed. Iodine-123-BZA scintig raphy appears to be a safe and useful agent for the detection and foll ow-up of patients with malignant melanoma. BZA also allowed the detect ion of unsuspected lesions and the evaluation of the results of variou s therapeutic procedures such as surgery, chemotherapy, immunobiology, biological therapy or radiotherapy.