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FAPI-CUP- Evaluating FAPI as a Novel Radiopharmaceutical for Cancer of Unknown Primary

RECRUITING

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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Study details:

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%.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-02-23

Primary completion: 2024-02-22

Study completion finish: 2024-02-22

Study type

DIAGNOSTIC

Phase

Trial ID

NCT05263700

Intervention or treatment

DRUG: 68Ga-FAPi-46

PROCEDURE: PET/CT imaging

Conditions

• Cancer of Unknown Primary Site

Image related to Cancer of Unknown Primary Site

Condition: Cancer of Unknown Primary Site
DRUG: 68Ga-FAPi-46 and other drugs
Bendigo, Victoria, Australia and more
Sponsor: Peter MacCallum Cancer Centre, Australia

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Bendigo Health

Research sites nearby

Select from list below to view details:

Bendigo Health
Bendigo, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
South West Healthcare
Warrnambool, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 68Ga-FAPI-PET/CT Patients receive 68Ga-FAPI IV then undergo PET/CT.	DRUG: 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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.	12 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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.	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.	12 months

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: FAPI-CUP- Evaluating FAPI as a Novel Radiopharmaceutical for Cancer of Unknown Primary