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

NCT05212103 | Enrolling By Invitation

• 1 other identifier: 1301/2022
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Melanoma; Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital, Turku PET Centre

Turku, Finland

Location

Related Publications (1)

• Dadson P, Yla-Outinen H, Kalliokoski K, Tuokkola T, Malaspina S, Koivumaki M, Viitanen R, Rajala N, Silvoniemi M, Tolvanen T, Nuutila P, Jalkanen S, Saraste A, Saaresranta T, Taimen P, Roivainen A. Proof-of-concept PET imaging of pulmonary sarcoidosis using VAP-1-targeted radiotracer [68Ga]Ga-DOTA-Siglec-9. Respir Res. 2025 Dec 19. doi: 10.1186/s12931-025-03455-8. Online ahead of print.

  PMID: 41420234 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum for determination of soluble VAP-1 level.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Melanoma; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anne Roivainen

  Turku University Hospital, Turku PET Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)