[68Ga]Ga-PentixaFor-PET Imaging for Staging of Marginal Zone Lymphoma

Inclusion criteria:

All patients must meet all of the following criteria:

1. Signed informed consent from the patient.

2. Patients of either gender, aged ≥ 18 years.

3. Patients with a histologically proven diagnosis of marginal zone lymphoma (MZL)according to the World Health Organization (WHO) classification of lymphoidneoplasms. Patients must have a biopsy-proven nodal, extranodal, or splenic MZL (atthe time of enrolment, the CXCR4 expression status will be unknown).

4. Treatment-naïve.

5. Negative pregnancy test in women capable of child-bearing and their agreement to usehighly effective contraception for 1 month after the last dose of [68Ga]Ga-PTF and [18F]FDG.

6. For male patients whose partner is of child-bearing potential: The patient iswilling to ensure that he and his partner use effective contraception for 1 monthafter the last dose of [68Ga]Ga-PTF and [18F]FDG.

7. Acceptable organ function, as evidenced by the following laboratory data:

8. No renal impairment: Estimated glomerular filtration rate (eGFR) > 30mL/min/1.73 m2or creatinine clearance > 60 mL/min by the Cockcroft-Gaultequation or equivalent

9. Total bilirubin ≤ 1.5 × ULN (upper limit of normal)

10. Serum albumin ≥ 2.5 g/dL.

11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULNor ≤ 5 × ULN in the presence of liver metastases

12. International normalized ratio (INR) < 1.3 or ≤ institutional ULN.

13. Life expectancy ≥ 12 weeks as estimated by the Investigator.

14. The patient must not have undergone any physical or pharmacological interventionwith curative or palliative intent between the time of any of the diagnosticmeasures and the [68Ga]Ga-PTF PET/CT and [18F]FDG PET/CT scan.

Exclusion criteria:

Patients will be excluded if one or more of the following criteria are met:

1. Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PTF and/or [18F]FDG investigational products.

2. Inability to lie still for the entire imaging time.

3. Any severe acute or active chronic infection, as judged by the Investigator, at thetime of screening or within two months prior to screening that may interfere withthe diagnostic properties of [68Ga]Ga-PTF PET/CT and/or [18F]FDG PET/CT imaging.

4. Patients with plasma glucose levels higher than 11 mmol/L or 200 mg/dL prior to [18F]FDG administration.

5. Administration of any anti-cancer therapy within 1 month prior to study entry.

6. Patients with complete resection of all tumor lesion(s).

7. Administration of another investigational medicinal product within 30 days or within 5 terminal elimination half-lives of previous investigational medicinal product,whichever is longer, prior to study entry.

8. Current greater than grade 2 toxicity from any reason, per US-NCI "CommonTerminology Criteria for Adverse Events v5.0" (NCI CTCAE 2017) except iftumor-related.

9. Pregnant or breast-feeding women.

10. Concomitant prohibited treatment which may interfere with [68Ga]Ga-PTF PET/CTimaging (systemic corticosteroids) administered within the last 1 month prior tostudy start.

11. Colony-stimulating factor (CSF) therapy within 5 days prior to [18F]FDG PET/CTexamination.

12. Any recent myocardial infarction, stroke, or osteomyelitis within two months priorscreening.

13. [18F]FDG PET/CT imaging or [68Ga]Ga-PTF PET imaging performed prior to study entry.

14. Judged by the referring physician as not mentally or as not physically fit tounderstand and comply with protocol-related interventions and procedures (e.g.,medically retarded, body weight > 180 kg for PET scanner).

15. Body weight of less than 48 kg.

16. Any other concurrently active neoplasia, or other disease who could jeopardize studysafety or data.