TheranosticTrials.org

Clinical Trial · NCT05263700

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

Overview

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.

Sponsor

Peter MacCallum Cancer Centre

Phase

N/A

Contacts

Linda Mileshkin (CONTACT)

nmresearch@petermac.org

+61 3 85595000

Research Manager (CONTACT)

nmresearch@petermac.org

ClinicalTrials.gov

NCT05263700

Drug / Compound

FAPI-46

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Haemoglobin ≥ 90g/L
  • Willing and able to comply with all study requirements, including all treatment and required assessments including follow-up procedures, in the investigator's judgment
  • 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
  • Absolute neutrophil count ≥1.5 x 109/L
  • Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); patients with known Gilbert's disease may have a bilirubin ≥ 3.0 x ULN
  • Platelet count ≥ 100 x 109/L
  • Life expectancy greater than 3 months
  • Aspartate transaminase (AST) or alanine transaminase (ALT) ≤2 x ULN (or ≤ 5 x ULN in the presence of liver metastases)
  • Creatinine clearance ≥ 30mL/min
  • Eastern Cooperative Oncology Group performance status 0 - 2
  • Adequate hematologic and organ function to commence systemic treatment, defined by the following laboratory results:

Exclusion

  • 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.
  • Adequately treated non-muscle invasive bladder cancer (Tis, Ta and low grade T1 tumours)
  • Known allergy or reaction to 18F or 68Ga tracer
  • 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
  • Uncontrolled medical or psychological conditions that may prevent commencement of systemic treatment.
  • Greater than one prior line of systemic treatment
  • Adequately treated carcinoma in situ without evidence of disease
  • Adequately treated basal cell or squamous cell skin carcinoma or non-invasive melanoma
  • 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)
  • Concurrent illness, including severe infection that may jeopardise the ability of the participant to undergo procedures outlined in this protocol with reasonable safety