Last updated: March 29, 2023
Sponsor: Peter MacCallum Cancer Centre, Australia
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT05263700
PMC71838
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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; adetailed clinical assessment; a CT scan of the chest/abdomen, and pelvis; pathologicalreview of tumour tissue; and other appropriate tests as per the Cancer Council OptimalCare 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 thefollowing 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 knownGilbert's disease may have a bilirubin ≥ 3.0 x ULN
- Aspartate transaminase (AST) or alanine transaminase (ALT) ≤2 x ULN (or ≤ 5 x ULNin the presence of liver metastases)
- Willing and able to comply with all study requirements, including all treatment andrequired assessments including follow-up procedures, in the investigator's judgment
Exclusion
Exclusion Criteria:
- Uncontrolled medical or psychological conditions that may prevent commencement ofsystemic treatment.
- Major surgical procedure within 6 weeks prior to study registration or activeinfection 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 theparticipant 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 ≥ 3yearsand of low potential risk of recurrence
- Adequately treated basal cell or squamous cell skin carcinoma or non-invasivemelanoma
- Adequately treated non-muscle invasive bladder cancer (Tis, Ta and low grade T1tumours)
- Adequately treated carcinoma in situ without evidence of disease
- Cancer subjects with incidental histologic findings of prostate cancer that, inthe opinion of the Investigator, is not deemed to require active therapy (e.g.,incidental prostate cancer identified following cystoprostatectomy that istumour/node/metastasis stage ≤ pT2N0)
- Greater than one prior line of systemic treatment
- Known allergy or reaction to 18F or 68Ga tracer
Study Design
Total Participants: 150
Study Start date:
February 23, 2022
Estimated Completion Date:
February 22, 2024
Study Description
Connect with a study center
Bendigo Health
Bendigo, Victoria 3550
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
South West Healthcare
Warrnambool, Victoria 3280
AustraliaSite Not Available
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