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An open-label study to explore the efficacy of NMK36 single-dose (i.v.) injection for diagnosis of regional lymph node metastasis in subjects with prostate cancer

An open-label study to explore the efficacy of NMK36 single-dose (i.v.) injection for diagnosis of regional lymph node metastasis in subjects with prostate cancer

38

In the safety analysis set, the age [mean (standard deviation), and the same hereafter] was 67.9 (5.4) years, and the weight was 66.19 (8.59) kg.

38 patients were enrolled in this study. Nine of the enrolled patients discontinuing the study prior to the study drug administration were excluded, and so there were 29 patients in the safety analysis set. 28 of these patients were included into FAS. None patients were excluded from FAS, and FAS gave a PPS of 28 patients.

Adverse events occurred in 2 of 29 patients in the safety analysis group. By symptom (PT), headache, dizziness postural and vessel puncture site erythema were each seen in one patient. All were mild in severity, and all resolved. In this study, no adverse reactions or deaths were reported. No serious adverse events were observed and no patients were withdrawn because of the development of adverse events. No clinically significant changes were observed in laboratory test values, vital signs and 12-lead electrocardiograms.

The diagnostic sensitivity of NMK36-PET/CT for metastatic regional lymph nodes with minor axes from 5 mm to <10 mm identified by pelvic contrast CT was 57.1%.

In terms of efficacy, the diagnostic specificity and accuracy of NMK36-PET/CT for metastatic regional lymph nodes with minor axes from 5 mm to <10 mm identified by pelvic contrast CT was 84.8% and 80.0%. As for the diagnostic sensitivity of maximal axes of the metastatic foci excited in metastatic regional lymph nodes with minor axes from 5 mm to <10 mm identified by pelvic contrast CT, maximal axes from 5 mm had a sensitivity of 60.0%, and maximal axes to <5mm had a sensitivity of 0.0%. There were 23 lymph nodes with minor axes from 5 mm to <10 mm that were not identified by pelvic contrast CT, but were identified in the same region as the evaluated nodes at the time of regional lymph node dissection, and two of them were diagnosed to be metastasis-positive by central pathological diagnosis. The results of NMK36-PET/CT in the same area as the metastasis-positive lymph nodes of these two patients were both negative. There was no tendency for the evaluated lymph nodes that were diagnosed as true-positive, false-positive, or false-negative by NMK36-PET/CT to be biased toward either low or high radioactivity dose. In terms of safety, no clinically significant adverse events were observed.

In terms of the diagnosis metastatic regional lymph node with minor axes from 5 mm to <10 mm, 4 of 7 lymph nodes judged as metastasis-positive by central pathological diagnosis were judged as positive by NMK36-PET/CT. The diagnostic sensitivity was 57.1%.

Sept. 01, 2019

https://pubmed.ncbi.nlm.nih.gov/31095314/

No

Nihon Medi-Physics Co., Ltd.

3-4-10, Shinsuna, Koto-ku, Tokyo 136-0075, Japan

Nihon Medi-Physics Co., Ltd.

3-4-10, Shinsuna, Koto-ku, Tokyo 136-0075, Japan

+81-3-5634-7363

completed

Dec. 22, 2014

Interventional

Non-randomized, open-label, uncontrolled

diagnostic purpose

2

-Patients with biopsy-proven prostate cancer.
-Patients who is scheduled for regional lymph node dissection.

-Patients with treated prostate cancer.
-Patients with another type of cancer.
-Patients with bone-marrow, hepatic or renal dysfunction.

Male

Prostate cancer

investigational material(s)
Generic name etc : fluciclovine(18F)
INN of investigational material : fluciclovine(18F)
Therapeutic category code : 43- Radioactive medicines
Dosage and Administration for Investigational material : A single administration was performed of the whole contents of 1 vial of NMK36 (2 mL; 185 MBq/2 mL when calibrated).

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

efficacy
Efficacy: diagnostic sensitivity of NMK36-PET/CT in diagnosing the metastatic regional lymph node

safety
efficacy
Efficacy:
-diagnostic specificity and accuracy of NMK36-PET/CT for metastatic regional lymph node
-diagnostic sensitivity of NMK36-PET/CT for metastatic regional lymph node (subgroup analysis for size of cancer)
-comparison of the diagnosis with NMK36-PET/CT images to the pathological findings in diagnosing the metastatic regional lymph node which was not identified by contrast-enhanced CT
-range of radioactivity dose
Safety:
subjective/objective symptoms, electrocardiogram exams, vital signs, laboratory tests

Oct. 17, 2014