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Trial registered on ANZCTR


Registration number
ACTRN12624001336572
Ethics application status
Approved
Date submitted
8/10/2024
Date registered
4/11/2024
Date last updated
4/11/2024
Date data sharing statement initially provided
4/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety of Fibroblast activation protein imaging in Single Photon Emission Computed Tomography/Computed Tomography (SPECT/CT)
Scientific title
Fibroblast Activation protein imaging research SPECT/CT (FIRST-NT): Assessing the safety and tolerability of 99mTc-3BP-4961 SPECT/CT in participants with clinical suspicion of active cancer
Secondary ID [1] 313104 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 335351 0
Condition category
Condition code
Cancer 331940 331940 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 329666 0
Diagnosis / Prognosis
Comparator / control treatment
No control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339538 0
Safety and tolerability to be assessed as composite primary outcome
Timepoint [1] 339538 0
At injection, within 7 days and within 28 days following injection (follow up visits)
Secondary outcome [1] 440381 0
Presence of number of positive lesions on IP SPECT imaging
Timepoint [1] 440381 0
At the end of the scan.
Secondary outcome [2] 440863 0
To assess the pharmacokinetics (PK) of 99Tc-3BP-4961
Timepoint [2] 440863 0
at 60, 120 and 180 minutes following injection.
Secondary outcome [3] 440864 0
Establish optimal timeframe to perform imaging of 99Tc-3BP-4961 with Single photoemission computed tomography (SPECT)
Timepoint [3] 440864 0
After the completion of scan

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 27180 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 43263 0
0810 - Tiwi

Funding & Sponsors
Funding source category [1] 317040 0
Government body
Name [1] 317040 0
NT Health
Country [1] 317040 0
Australia
Primary sponsor type
Government body
Name
NT health
Address
Country
Australia
Secondary sponsor category [1] 319854 0
None
Name [1] 319854 0
None
Address [1] 319854 0
Country [1] 319854 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315796 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 315796 0
https://www.menzies.edu.au/page/About_Us/Menzies_committees/Human_research_ethics_committee/
Ethics committee country [1] 315796 0
Australia
Date submitted for ethics approval [1] 315796 0
03/07/2024
Approval date [1] 315796 0
20/08/2024
Ethics approval number [1] 315796 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135822 0
Dr Joshua James Morigi
Address 135822 0
105 Rocklands Drive, Royal Darwin Hospital, TIWI 0810 NT
Country 135822 0
Australia
Phone 135822 0
+61 08 89226542
Fax 135822 0
Email 135822 0
[email protected]
Contact person for public queries
Name 135823 0
Joshua James Morigi
Address 135823 0
105 Rocklands Drive, Royal Darwin Hospital, TIWI 0810 NT
Country 135823 0
Australia
Phone 135823 0
+61 08 89226542
Fax 135823 0
Email 135823 0
[email protected]
Contact person for scientific queries
Name 135824 0
Joshua James Morigi
Address 135824 0
105 Rocklands Drive, Royal Darwin Hospital, TIWI 0810 NT
Country 135824 0
Australia
Phone 135824 0
+61 08 89226542
Fax 135824 0
Email 135824 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.