FAPI-CUP- Evaluating FAPI as a Novel Radiopharmaceutical for Cancer of Unknown Primary (FAPI-CUP)
Primary Purpose
Cancer of Unknown Primary Site
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
68Ga-FAPi-46
PET/CT imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Cancer of Unknown Primary Site focused on measuring FAPI, PET/CT, CUP, FAPI-46
Eligibility Criteria
Inclusion Criteria:
- Participant has provided written informed consent
- Participants aged 18 years or over at screening
- 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
- Has not commenced current line of systemic treatment
- Eastern Cooperative Oncology Group performance status 0 - 2
- Life expectancy greater than 3 months
Adequate hematologic and organ function to commence systemic treatment, defined by the following laboratory results:
- Haemoglobin ≥ 90g/L
- Absolute neutrophil count ≥1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Creatinine clearance ≥ 30mL/min
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); patients with known Gilbert's disease may have a bilirubin ≥ 3.0 x ULN
- Aspartate transaminase (AST) or alanine transaminase (ALT) ≤2 x ULN (or ≤ 5 x ULN in the presence of liver metastases)
- Willing and able to comply with all study requirements, including all treatment and required assessments including follow-up procedures, in the investigator's judgment
Exclusion Criteria:
- Uncontrolled medical or psychological conditions that may prevent commencement of systemic treatment.
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.
- Concurrent illness, including severe infection that may jeopardise the ability of the participant to undergo procedures outlined in this protocol with reasonable safety
Prior cancer diagnosis with the exception of:
- Malignancy treated with curative intent and with no known active disease ≥ 3years and of low potential risk of recurrence
- Adequately treated basal cell or squamous cell skin carcinoma or non-invasive melanoma
- Adequately treated non-muscle invasive bladder cancer (Tis, Ta and low grade T1 tumours)
- Adequately treated carcinoma in situ without evidence of disease
- 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)
- Greater than one prior line of systemic treatment
- Known allergy or reaction to 18F or 68Ga tracer
Sites / Locations
- Bendigo HealthRecruiting
- Peter MacCallum Cancer CentreRecruiting
- South West Healthcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-FAPI-PET/CT
Arm Description
Patients receive 68Ga-FAPI IV then undergo PET/CT.
Outcomes
Primary Outcome Measures
The proportion of patients in which a likely tissue of origin is identified using 68Ga-FAPI-PET/CT
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.
Secondary Outcome Measures
Maximum Standard Uptake Value measured on 68Ga-FAPI-PET/CT
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.
The proportion of patients in which the choice of treatment is changed after the 68Ga-FAPI-PET/CT
The change in patient management/treatment pre- and post- 68Ga-FAPI-PET/CT.
Full Information
NCT ID
NCT05263700
First Posted
February 15, 2022
Last Updated
March 29, 2023
Sponsor
Peter MacCallum Cancer Centre, Australia
1. Study Identification
Unique Protocol Identification Number
NCT05263700
Brief Title
FAPI-CUP- Evaluating FAPI as a Novel Radiopharmaceutical for Cancer of Unknown Primary
Acronym
FAPI-CUP
Official Title
FAPI-CUP - Evaluating FAPI as a Novel Radiopharmaceutical Targeting Cancer-associated Fibroblasts for the Diagnosis of Patients With Cancer of Unknown Primary
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
February 22, 2024 (Anticipated)
Study Completion Date
February 22, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peter MacCallum Cancer Centre, Australia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Cancers of unknown primary (CUP) account for 3-5% of all malignancies. The prognosis of patients diagnosed with CUP is poor, with a median overall survival of 9-12 months. Despite improvements in conventional diagnostic processes, the tissue of origin (ToO) is identified in <30% of CUP patients. PET/CT is increasingly used to determine the ToO, with the most commonly used PET radiotracer being the glucose analogue fluorine-18 fluorodeoxyglucose (FDG). Although PET/CT can change CUP patient management and identify primary sites, FDG has limited sensitivity for detecting some cancers, such as CUP. It has been reported that fibroblast activation protein (FAP) is highly expressed in some tumours, including CUP. 68Ga-FAPI (experimental drug) is a radiotracer that can specifically bind to FAP, and may enable the primary cancer site to be viewed using PET imaging. It is hypothesised that the use of 68Ga-FAPI-PET/CT will increase likely ToO diagnosis from 30% with current standard of care to 60%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Unknown Primary Site
Keywords
FAPI, PET/CT, CUP, FAPI-46
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective single arm cohort study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-FAPI-PET/CT
Arm Type
Experimental
Arm Description
Patients receive 68Ga-FAPI IV then undergo PET/CT.
Intervention Type
Drug
Intervention Name(s)
68Ga-FAPi-46
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PET/CT imaging
Intervention Description
PET with the investigational tracer 68Ga-FAPI-46 with accompanying low-dose CT for anatomical localisation
Primary Outcome Measure Information:
Title
The proportion of patients in which a likely tissue of origin is identified using 68Ga-FAPI-PET/CT
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Maximum Standard Uptake Value measured on 68Ga-FAPI-PET/CT
Description
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.
Time Frame
12 months
Title
The proportion of patients in which the choice of treatment is changed after the 68Ga-FAPI-PET/CT
Description
The change in patient management/treatment pre- and post- 68Ga-FAPI-PET/CT.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant has provided written informed consent
Participants aged 18 years or over at screening
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
Has not commenced current line of systemic treatment
Eastern Cooperative Oncology Group performance status 0 - 2
Life expectancy greater than 3 months
Adequate hematologic and organ function to commence systemic treatment, defined by the following laboratory results:
Haemoglobin ≥ 90g/L
Absolute neutrophil count ≥1.5 x 109/L
Platelet count ≥ 100 x 109/L
Creatinine clearance ≥ 30mL/min
Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); patients with known Gilbert's disease may have a bilirubin ≥ 3.0 x ULN
Aspartate transaminase (AST) or alanine transaminase (ALT) ≤2 x ULN (or ≤ 5 x ULN in the presence of liver metastases)
Willing and able to comply with all study requirements, including all treatment and required assessments including follow-up procedures, in the investigator's judgment
Exclusion Criteria:
Uncontrolled medical or psychological conditions that may prevent commencement of systemic treatment.
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.
Concurrent illness, including severe infection that may jeopardise the ability of the participant to undergo procedures outlined in this protocol with reasonable safety
Prior cancer diagnosis with the exception of:
Malignancy treated with curative intent and with no known active disease ≥ 3years and of low potential risk of recurrence
Adequately treated basal cell or squamous cell skin carcinoma or non-invasive melanoma
Adequately treated non-muscle invasive bladder cancer (Tis, Ta and low grade T1 tumours)
Adequately treated carcinoma in situ without evidence of disease
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)
Greater than one prior line of systemic treatment
Known allergy or reaction to 18F or 68Ga tracer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Mileshkin
Phone
+61 3 85595000
Email
NMResearch@petermac.org
First Name & Middle Initial & Last Name or Official Title & Degree
Research Manager
Email
NMResearch@petermac.org
Facility Information:
Facility Name
Bendigo Health
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Warren
Phone
+61 3 5454 7210
Email
cancerresearch@bendigohealth.org.au
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Mileshkin
Email
NMResearch@petermac.org
Facility Name
South West Healthcare
City
Warrnambool
State/Province
Victoria
ZIP/Postal Code
3280
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Collins
Email
swhct@swh.net.au
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
FAPI-CUP- Evaluating FAPI as a Novel Radiopharmaceutical for Cancer of Unknown Primary
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