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RecruitingLast updated: 18 February 2026

FAPI-CUP: A study designed to evaluate the diagnostic ability of a targeted scan in determining the likely tissue origin in people with Cancer Unknown Primary (CUP) not identified by standard of careEvaluating FAPI as a Novel Radiopharmaceutical Targeting Cancer-associated Fibroblasts for the Diagnosis of Patients With Cancer of Unknown Primary

Trial purpose

Medical clipboardDiagnostic

Tumor type

Cancer of Unknown Primary Cancer of Unknown Primary

Age

People18+

Trial acronym

FAPI-CUP

Clinical summary

Summary

You may be eligible for this study if you have cancer of unknown primary (CUP) and are either treatment naïve or starting second-line treatment.

CUP account for 3-5% of all malignancies. The prognosis of people 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 less than 30% of CUP patients.

PET/CT scans are increasingly used to determine the ToO, with the most commonly used PET radiotracer being the glucose analogue fluorine-18 fluorodeoxyglucose (FDG). Although PET/CT scans 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 (the study 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%.

Eligible participants will receive 68Ga-FAPI-PET/CT imaging.

Conditions

This trial is treating people with cancer of unknown primary location

Eligibility

Inclusion

  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

Exclusion

  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

Inclusion

  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Peter MacCallum Cancer Centre, Australia

Scientific Title

Evaluating FAPI as a Novel Radiopharmaceutical Targeting Cancer-associated Fibroblasts for the Diagnosis of Patients With Cancer of Unknown Primary

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