Cancer of Unknown Primary SiteFAPI-CUPNCT05263700
FAPI-CUP- Evaluating FAPI as a Novel Radiopharmaceutical for Cancer of Unknown Primary
A study testing 68Ga-FAPi-46 and PET/CT imaging in people with Cancer of Unknown Primary Site, run by Peter MacCallum Cancer Centre, Australia at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Unknown Primary Site
- What is being tested?
- 68Ga-FAPi-46 and PET/CT imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesAustralia
- Study dates
- 23 Feb 2022to 22 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Research Manager contact
Australia3 sites, 3 recruiting
- Recruiting
Bendigo Health
Bendigo, Victoria, 3550
Mark Warren, +61 3 5454 7210, cancerresearch@bendigohealth.org.au
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Linda Mileshkin, NMResearch@petermac.org
- Not yet recruiting
South West Healthcare
Warrnambool, Victoria, 3280
Ian Collins, swhct@swh.net.au
About this study
Official title: FAPI-CUP - Evaluating FAPI as a Novel Radiopharmaceutical Targeting Cancer-associated Fibroblasts for the Diagnosis of Patients With Cancer of Unknown Primary
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.
Read the 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%.
- Conditions
- Cancer of Unknown Primary Site
- Being tested
- 68Ga-FAPi-46, PET/CT imaging
- Keywords
- FAPI, PET/CT, CUP, FAPI-46
- Medical subject headings
- Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPi-46Drug
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.
PET/CT imagingProcedure or surgery
PET with the investigational tracer 68Ga-FAPI-46 with accompanying low-dose CT for anatomical localisation
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI-PET/CT | Experimental | Patients receive 68Ga-FAPI IV then undergo PET/CT. Receives: Drug: 68Ga-FAPi-46; Procedure: PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start23 Feb 2022
- Primary completion22 Feb 2024 (estimated)
- Study completion22 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Unknown Primary SiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective single arm cohort study.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263700
- Sponsor's protocol ID
- PMC71838
- Acronym
- FAPI-CUP
- Status last verified
- Mar 2023
- First submitted
- 15 Feb 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAPI-CUP - Evaluating FAPI as a Novel Radiopharmaceutical Targeting Cancer-associated Fibroblasts for the Diagnosis of Patients With Cancer of Unknown Primary
- ClinicalTrials.gov ID
- NCT05263700
- Acronym / sponsor ID
- FAPI-CUP / PMC71838
- Conditions
- Cancer of Unknown Primary Site
- Keywords
- FAPI, PET/CT, CUP, FAPI-46
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 22 Feb 2024 (estimated)
- Study completion
- 22 Feb 2024 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective single arm cohort study.
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI-PET/CT | Experimental | Drug: 68Ga-FAPi-46, Procedure: PET/CT imagingPatients receive 68Ga-FAPI IV then undergo PET/CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (12 listed)
- 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
- 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:
- Greater than one prior line of systemic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPi-46FAPI-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. | Drug | 68Ga-FAPI-PET/CT |
| PET/CT imagingPET with the investigational tracer 68Ga-FAPI-46 with accompanying low-dose CT for anatomical localisation | Procedure or surgery | 68Ga-FAPI-PET/CT |
Primary outcome
The proportion of patients in which a likely tissue of origin is identified using 68Ga-FAPI-PET/CT
Time frame: 12 months
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.
2 secondary outcomes
Maximum Standard Uptake Value measured on 68Ga-FAPI-PET/CT
Time frame: 12 months
The proportion of patients in which the choice of treatment is changed after the 68Ga-FAPI-PET/CT
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Research Manager contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-FAPi-46 and PET/CT imaging in people with Cancer of Unknown Primary Site, run by Peter MacCallum Cancer Centre, Australia at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Mileshkin (+61 3 85595000, NMResearch@petermac.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients in which a likely tissue of origin is identified using 68Ga-FAPI-PET/CT (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.