The subjects to be included in this study have been diagnosed with primary breast, lung (non-small cell), ovarian or prostate cancer or malignant melanoma and have metastatic spread of the cancer to liver, lungs, bone or brain. The metastases must have been diagnosed by contrast-enhanced CT, contrast-enhanced MRI or bone scintigraphy (as appropriate).
Conditions
Interventions
Product Name: Kit for the preparation of 99mTc-NC100692 Injection
Pharmaceutical Form: Kit for radiopharmaceutical preparation
CAS Number: 489427-17-0
Current Sponsor code: NC100692
Concentration unit
Sponsors
Amersham plc and its Amersham Health affiliates, trading as GE Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects may be included in the study if they meet all of the following criteria: (1) The subject is over 18 years old. (2) The subject is male, or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), or if of childbearing potential the results of a urine human chorionic gonadotropin pregnancy test, performed on the same day as and with the result known before 99mTc NC100692 administration, must be negative. (3) The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained. (4) The subject has been diagnosed with metastases (minimum of 1 lesion >1 cm and presence of at least 2 bone lesions if bone is the only site of metastasis) to the liver, lungs, bone and/or brain from one of the following primary malignant lesions: • Primary breast cancer. • Primary non-small cell lung cancer. • Primary malignant melanoma. • Primary ovarian cancer. • Primary prostate cancer. The primary tumour needs to be histopathologically proven as malignant in the subject’s records. (5) At least one lesion that has not been irradiated. This lesion can be a new lesion in an earlier irradiated field. (6) The subject has a clinically acceptable (as judged by the investigator) renal and hepatic history and physical examination at screening and is capable of self care such that the subject has a high chance of completing the study. (7) The subject has fully recovered from toxic effects. (8) Prior cancer-related hormonotherapy is allowed providing an approximately 4 weeks delay between the last treatment and study entry. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects must be excluded from participating in this study if they meet any of the following criteria: (1) The subject was previously included in this study. (2) The subject has received another IMP within 30 days before or is scheduled to receive one within 24 hours after 99mTc NC100692 Injection administration, or will receive an IMP within the follow up period proposed for this study. (3) The subject has known allergies to any product used in this study or its constituents (e.g., para-amino benzoic acid). (4) The subject has been treated with systemic chemotherapy in the 2 months before enrolment. (5) The subject has been treated with radiation therapy in the 4 weeks before enrolment, or in the case of extensive radiation therapy in the 8 weeks before enrolment. (6) The subject is lactating. (7) The subject undergoes monitoring of occupational radiation exposure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the feasibility of detecting metastatic lesions located in liver, lung, bone and brain using scintigraphic imaging following the administration of 99mTc NC100692 Injection in subjects with primary cancer in the breast, lung (non-small cell), ovary, or prostate or with melanoma, and compare to current anatomical imaging for detection of metastases.;Secondary Objective: To assess the ability of 99mTc NC100692 Injection scintigraphic imaging to detect the response of metastases to treatment after approximately 3 weeks of therapy. To assess the safety profile of repeat dosing with 99mTc-NC100692 Injection in subjects with metastatic cancer. ;Primary end point(s): The primary efficacy endpoint in this study is the match (number of correctly identified lesions) between lesions detected from the scintigraphic images compared to those detected by the reference standard. The scintigraphic images before and after treatment will be evaluated by the on site investigators for a qualitative change in lesion appearance (number and size). These results will be compared to the standard evaluation of response of metastases to treatment at the site. | — |
Countries
Germany, Spain, Sweden, United Kingdom
Outcome results
None listed