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

NCT05263700 | Unknown

• 1 other identifier: PMC71838
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer of Unknown Primary Site

Keywords

FAPI; PET/CT; CUP; FAPI-46

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maximum Standard Uptake Value measured on 68Ga-FAPI-PET/CT

  12 months

• The proportion of patients in which the choice of treatment is changed after the 68Ga-FAPI-PET/CT

  12 months

Study Arms (1)

68Ga-FAPI-PET/CT

EXPERIMENTAL

Patients receive 68Ga-FAPI IV then undergo PET/CT.

Drug: 68Ga-FAPi-46; Procedure: PET/CT imaging

Interventions

68Ga-FAPi-46 DRUG

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.

68Ga-FAPI-PET/CT

PET/CT imaging PROCEDURE

PET with the investigational tracer 68Ga-FAPI-46 with accompanying low-dose CT for anatomical localisation

68Ga-FAPI-PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead

Study Sites (3)

Bendigo Health

Bendigo, Victoria, 3550, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

South West Healthcare

Warrnambool, Victoria, 3280, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Interventions

FAPI-46

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Linda Mileshkin

CONTACT

+61 3 85595000; NMResearch@petermac.org

Research Manager

CONTACT

NMResearch@petermac.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective single arm cohort study.

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 3, 2022
• Study Start: February 23, 2022
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)