Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer

Study Overview
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Brief Summary
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To evaluate the normal physiological distribution of positron nuclide labeled DOTA-FAPI PET/CT in human body and its diagnostic efficiency for colorectal cancers

Detailed Description
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Participants first undergo an 18F-FDG PET/CT, followed by 68Ga-FAPI04 PET/CT in groups. The purpose of the study is to explore the possibility of superiority of FAPI in diagnosis of colorectal cancer (TNM staging) by the comparison of the two tracers uptake (the maximum of standardized uptake value, SUVmax). Histopathology and conventional imaging follow-up are served as the reference standard.

Official Title
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Comparison of Positron Nuclide Labeled DOTA-FAPI PET and FDG PET Study in Colocrectal Cancer

Conditions
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Tumor, Solid, Positron-Emission Tomography, Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: 18F-FDG and 68Ga-DOTA-FAPI04 PET/CT
* Diagnostic Test: 18F-FDG and 18F-DOTA-FAPI04 PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ECOG score 0-2 patients with newly diagnosed or previously treated colorectal cancers patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for tumor staging to decide the most proper treatment strategy patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT to detect tumor recurrence and metastases (repeat staging) expected survival ≥12 weeks blood routine, liver and kidney function meet the following criteria : blood routine: WBC≥4.0×109L or neutrophils ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L;PT and APTT ULN 1.5 or less; Liver and kidney function: t-bil ≤1.5×ULT(upper limit of normal value), ALT/AST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis);BUN 1.5 x or less ULT, SCr 1.5 x or less ULT at least one measurable target lesion according to RECIST1.1 women must use effective contraception during the study period and for 6 months after the end of the study (effective contraception means sterilization, hormone devices, condoms, contraceptives/pills, abstinence or vasectomy by a partner, etc.);Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period able to understand and sign the informed consent voluntarily, with good compliance. Exclusion Criteria: severe abnormalities of liver and kidney function; women preparing for pregnancy, pregnancy and lactation; cannot lie supine for half an hour; refuse to join the clinical researcher; suffering from claustrophobia or other mental illness;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-DOTA-FAPI04<br>Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI04, and undergo PET/CT imaging within the specified time | Diagnostic Test: 18F-FDG and 68Ga-DOTA-FAPI04 PET/CT<br>* Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI04, and undergo PET/CT imaging within the specified time<br>|
| Experimental: 18F-DOTA-FAPI04<br>Each subject receive a single intravenous injection of 18F-FDG and 18F-DOTA-FAPI04, and undergo PET/CT imaging within the specified time | Diagnostic Test: 18F-FDG and 18F-DOTA-FAPI04 PET/CT<br>* Each subject receive a single intravenous injection of 18F-FDG and 18F-DOTA-FAPI04, and undergo PET/CT imaging within the specified time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| finial clinical staging（TNM） | To explore the effect of FAPI PET/CT on staging of Colorectal cancer by comparing with FDG PET/CT | 60-120days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVmax | To compare the uptake （SUVmax）of two tracers （FAPI and FDG）in colorectal cancer (including the normal organs, primary tumors and metastases) | 60-120days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Positron-Emission Tomography, FAPI