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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05263700
Registration number
NCT05263700
Ethics application status
Date submitted
15/02/2022
Date registered
3/03/2022
Titles & IDs
Public title
FAPI-CUP- Evaluating FAPI as a Novel Radiopharmaceutical for Cancer of Unknown Primary
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Scientific title
FAPI-CUP - Evaluating FAPI as a Novel Radiopharmaceutical Targeting Cancer-associated Fibroblasts for the Diagnosis of Patients With Cancer of Unknown Primary
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Secondary ID [1]
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PMC71838
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Universal Trial Number (UTN)
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Trial acronym
FAPI-CUP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer of Unknown Primary Site
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 68Ga-FAPi-46
Treatment: Surgery - PET/CT imaging
Experimental: 68Ga-FAPI-PET/CT - Patients receive 68Ga-FAPI IV then undergo PET/CT.
Treatment: Drugs: 68Ga-FAPi-46
FAPI-46 is a small molecular radiopharmaceutical that binds to the fibroblast activated protein on cancer associated fibroblasts. Gallium-68 (68Ga) is a positron-emitting isotope with a half-life of 68 minutes.
Treatment: Surgery: PET/CT imaging
PET with the investigational tracer 68Ga-FAPI-46 with accompanying low-dose CT for anatomical localisation
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The proportion of patients in which a likely tissue of origin is identified using 68Ga-FAPI-PET/CT
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Assessment method [1]
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The proportion of patients in which 68Ga-FAPI-PET/CT identifies a likely Tissue of Origin (ToO) beyond that identified by standard of care (SoC) testing.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Maximum Standard Uptake Value measured on 68Ga-FAPI-PET/CT
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Assessment method [1]
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The average SUVmax of the 5 most intense lesions measured on 68Ga-FAPI-PET/CT based on the best overall response rate assessed via RECIST after commencement of systemic therapy.
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Timepoint [1]
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12 months
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Secondary outcome [2]
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The proportion of patients in which the choice of treatment is changed after the 68Ga-FAPI-PET/CT
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Assessment method [2]
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The change in patient management/treatment pre- and post- 68Ga-FAPI-PET/CT.
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Timepoint [2]
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12 months
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Eligibility
Key inclusion criteria
1. Participant has provided written informed consent
2. Participants aged 18 years or over at screening
3. Diagnosed with CUP based on a diagnostic work-up, including, but not limited to; a detailed clinical assessment; a CT scan of the chest/abdomen, and pelvis; pathological review of tumour tissue; and other appropriate tests as per the Cancer Council Optimal Care Pathway guidelines
4. Has not commenced current line of systemic treatment
5. Eastern Cooperative Oncology Group performance status 0 - 2
6. Life expectancy greater than 3 months
7. Adequate hematologic and organ function to commence systemic treatment, defined by the following laboratory results:
1. Haemoglobin = 90g/L
2. Absolute neutrophil count =1.5 x 109/L
3. Platelet count = 100 x 109/L
4. Creatinine clearance = 30mL/min
5. Serum bilirubin = 1.5 x upper limit of normal (ULN); patients with known Gilbert's disease may have a bilirubin = 3.0 x ULN
6. Aspartate transaminase (AST) or alanine transaminase (ALT) =2 x ULN (or = 5 x ULN in the presence of liver metastases)
8. Willing and able to comply with all study requirements, including all treatment and required assessments including follow-up procedures, in the investigator's judgment
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Uncontrolled medical or psychological conditions that may prevent commencement of systemic treatment.
2. Major surgical procedure within 6 weeks prior to study registration or active infection requiring systemic treatment
a. Placement of vascular access devices is not considered major surgery.
3. Concurrent illness, including severe infection that may jeopardise the ability of the participant to undergo procedures outlined in this protocol with reasonable safety
4. Prior cancer diagnosis with the exception of:
1. Malignancy treated with curative intent and with no known active disease = 3years and of low potential risk of recurrence
2. Adequately treated basal cell or squamous cell skin carcinoma or non-invasive melanoma
3. Adequately treated non-muscle invasive bladder cancer (Tis, Ta and low grade T1 tumours)
4. Adequately treated carcinoma in situ without evidence of disease
5. Cancer subjects with incidental histologic findings of prostate cancer that, in the opinion of the Investigator, is not deemed to require active therapy (e.g., incidental prostate cancer identified following cystoprostatectomy that is tumour/node/metastasis stage = pT2N0)
5. Greater than one prior line of systemic treatment
6. Known allergy or reaction to 18F or 68Ga tracer
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
22/02/2024
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Bendigo Health - Bendigo
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [3]
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South West Healthcare - Warrnambool
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Recruitment postcode(s) [1]
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3550 - Bendigo
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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3280 - Warrnambool
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a prospective single arm cohort study designed to evaluate the diagnostic ability of 68Ga-FAPI-PET/CT scan in determining likely tissue of origin in Cancer of Unknown Primary (CUP) patients not identified by standard of care. Patients with CUP will be either treatment naïve or starting second-line treatment.
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Trial website
https://clinicaltrials.gov/study/NCT05263700
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Linda Mileshkin
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Address
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Country
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Phone
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+61 3 85595000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05263700