An open-label, multi-centre, phase 2a study to assess the feasibility and safety of intravenous bolus administration of 99mTc-NC100692 Injection in imaging metastases in late stage cancer patients.
- Conditions
- 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).
- Registration Number
- EUCTR2004-004010-17-DE
- Lead Sponsor
- Amersham plc and its Amersham Health affiliates, trading as GE Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method