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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
Date last updated
31/03/2023

Titles & IDs
Public title
FAPI-CUP- Evaluating FAPI as a Novel Radiopharmaceutical for Cancer of Unknown Primary
Scientific title
FAPI-CUP - Evaluating FAPI as a Novel Radiopharmaceutical Targeting Cancer-associated Fibroblasts for the Diagnosis of Patients With Cancer of Unknown Primary
Secondary ID [1] 0 0
PMC71838
Universal Trial Number (UTN)
Trial acronym
FAPI-CUP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer of Unknown Primary Site 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of patients in which a likely tissue of origin is identified using 68Ga-FAPI-PET/CT
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Maximum Standard Uptake Value measured on 68Ga-FAPI-PET/CT
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
The proportion of patients in which the choice of treatment is changed after the 68Ga-FAPI-PET/CT
Timepoint [2] 0 0
12 months

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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/02/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Bendigo Health - Bendigo
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
South West Healthcare - Warrnambool
Recruitment postcode(s) [1] 0 0
3550 - Bendigo
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
3280 - Warrnambool

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05263700
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Linda Mileshkin
Address 0 0
Country 0 0
Phone 0 0
+61 3 85595000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05263700