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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05212103
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Turku University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Anne Roivainen
Principal Investigator Affiliation	Turku University Hospital, Turku PET Centre
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	Finland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Acute Myeloid Leukemia, Melanoma, Non Small Cell Lung Cancer

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Turku 633679, Finland

Status

Address

Turku University Hospital, Turku PET Centre

Turku 633679, ,

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