None listed
Conditions
Brief summary
The aim of this study is assessing the safety and tolerability of a single administration of an experimental radiotracer 99mTc-3BP-4961 (Investigational product or IP) and then perform a single photon emission computed tomography (SPECT) scan. Who is it for? You may be eligible for this study if you are male or female over 18 years of age, presenting with clinical suspicion of active cancer during investigation for a possible new cancer diagnosis profession in a patient with know solid tumour. Study details Participants will receive a single IP intravenous administration of 10-15MBq /Kg of 99mTc-3BP-4961 but not more than 1200 MBq total. Participants will then be scanned using SPECT and CT for cancer lesion. After completion of the intervention, participants will be assessed for safety and tolerability using laboratory parameters and observation of adverse events. It is hoped that findings from this study will help further investigation for histopathological confirmation or tumour presence or tumour recurrence. Note: this brief summary is intended for lay audience.
Interventions
Single Investigational Product (IP) intravenous administration of 10-15 MBq /Kg of 99mTc-3BP-4961 but not more than 1200 MBq total based on the participant's weight.
Adherence to intervention will be assessed via laboratory tests and compiling of forms for determination of adverse events
Sponsors
NT health
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- 18 years of age and over - Presenting with clinical suspicion of active cancer during investigation for a possible new cancer diagnosis progression in a patient with known solid tumor - Results of the fluorodeoxiglucose (FDG) positron emission tomography (PET)/ computed tomography (CT) scan confirm the clinical suspicion of active disease likely to represent cancer - Patient is willing and able to consent to the study - Patient is Eastern cooperative oncology group (ECOG) performance status of 0-2. - Adequate bone marrow reserve and organ function demonstrated by complete blood count and biochemistry at screening: • Haemoglobin (Hb): >8.0 g / dL • Platelet count >50.000 / mm3 • Negative pregnancy test
Exclusion criteria
° Persons under 18 years of age • Patients who have received any systemic treatment for cancer (chemotherapy or immunotherapy) within the last 4 weeks prior to FDG PET/CT. • Pregnant patients • Patients unable to consent • Patients with known cognitive or physical disability. • Patients with known difficulties in cannulation • Patients with endstage renal failure (ESRF), severe urinary incontinence, hydronephrosis. • Patients with uncontrolled pain or other symptom resulting in inability to comply with imaging procedures • Known allergy, hypersensitivity to the IP or its excipients • Patient unlikely to comply with study procedures for any other reason as judged by the Principal investigator
Outcome results
None listed