Clinical trial NCT05212103: PET Imaging of Cancer Patients Using 68Ga-DOTA-Siglec-9
Official title: PET Imaging of Cancer Patients Using 68Ga-DOTA-Siglec-9
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Myeloid Leukemia
Melanoma
Non Small Cell Lung Cancer
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2022-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of Turku University Hospital with acute myeloid leukemia (AML), metastatic melanoma and metastatic non-small cell lung cancer (NSCLC) (stage IV)

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: 68Ga-DOTA-Siglec-9 uptake in bone marrow and cancerous lesions
timeFrame: within a 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital, Turku PET Centre
Study officials:
affiliation: Turku University Hospital, Turku PET Centre
name: Anne Roivainen
role: PRINCIPAL_INVESTIGATOR
References: