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NCT05212103 Clinical Trial

PET Imaging of Cancer Patients Using 68Ga-DOTA-Siglec-9

Melanoma Clinical Trial

— CANSI  

Official title:
PET Imaging of Cancer Patients Using 68Ga-DOTA-Siglec-9

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05212103
Other study ID # 1301/2022
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date December 31, 2026

Study information
Verified date October 2023
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a scientific study to determine expression of vascular adhesion protein 1 (VAP-1) in cancer patients by 68Ga-DOTA-Siglec-9 positron emission tomography/computed tomography (PET/CT) before and after cancer treatment.

Description:

The purpose of this study is to evaluate expression of vascular adhesion protein 1 (VAP-1) in bone marrow and cancerous lesions before and after therapy using 68Ga-DOTA-Siglec-9 positron emission tomography/computed tomography (PET/CT). Patients with acute myeloid leukemia (AML) that undergo bone marrow transplantation and patients with melanoma and lung cancer that undergo chemotherapy will be studied. In addition, imaging results will be compared with clinical data and research data from blood samples. The study is of great clinical importance as other methods do not provide such comprehensive information on the presence of the VAP-1 molecule in the body, especially in the bone marrow and cancer tissue before and after cancer treatment. Research is also important for drug development targeting VAP-1.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 30
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Diagnosis of acute myeloid leukemia (AML) and fit for allogeneic hematopoietic stem cell transplantation (alloHSCT), as assessed in the standard operating procedures. - Diagnosis of metastatic melanoma and fit for immune checkpoint inhibitors or BRAF- and MEK inhibitors. - Diagnosis of metastatic non-small cell lung cancer (NSCLC) (stage IV) and fit for immune checkpoint inhibitors and/or chemotherapy. - Able and willing to give written informed consent and to comply with the study protocol. Exclusion Criteria: - Unsuitable for alloHSCT (AML), checkpoint inhibitors or BRAF- and MEK inhibitors (melanoma or checkpoint inhibitors and/or chemotherapy (NSCLC) according to the standard operating procedures. - Unable or unwilling to comply with the study protocol for any reason. - Evidence of significant uncontrolled concomitant diseases such as neurological, renal, hepatic, endocrine, or gastrointestinal disorders which, in the opinion of the Investigator, would preclude patient participation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Finland Turku University Hospital, Turku PET Centre Turku

Sponsors (1)
Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 68Ga-DOTA-Siglec-9 uptake in bone marrow and cancerous lesions Standardized uptake value of PET tracer 68Ga-DOTA-Siglec-9 in the bone marrow and cancerous lesions within a 1 day
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