An Open-label, Single-arm, Single-center Study to Evaluate the Diagnostic Efficacy of a Novel PET Probe, 68Ga-SFB6-ZN01, in Patients With Malignant Tumors

NCT07420036 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2025LCYJZX-ZD004
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to test a new imaging agent called 68Ga-SFB6-ZN01, which helps visualize tumors using PET/CT scans. The agent attaches to a protein called integrin αvβ6, which is found on the surface of many cancer cells but rarely on normal cells. A total of 98 adults who either have a confirmed cancer diagnosis, are strongly suspected of having cancer, or may have recurrent cancer after previous treatment will be enrolled. Each participant will receive a single injection of 68Ga-SFB6-ZN01 and undergo one PET/CT scan within one week of joining the study. The main goals are: to see how safe the imaging agent is and whether it causes any side effects; to understand how the agent distributes in the body, and how much radiation exposure it gives; to determine how accurately 68Ga-SFB6-ZN01 PET/CT can detect cancerous lesions and correctly stage the disease, using biopsy results or long-term follow-up (≥6 months) as the reference standard; to explore whether the PET signal intensity (e.g., SUVmax) correlates with the expression of integrin αvβ6 in the tumor tissue. No therapeutic treatment is given in this study. Participation involves one imaging visit and follow-up contact. The results will help determine whether this new tracer should be developed further for cancer imaging.

Conditions

Neoplasms

Keywords

68Ga-SFB6-ZN01; Integrin αvβ6; PET/CT; Positron Emission Tomography; Diagnostic Accuracy; Sensitivity and Specificity; Biodistribution; Radiation Dosimetry; Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Diagnostic Efficacy of 68Ga-SFB6-ZN01 PET/CT in Malignant Solid Tumors

  Sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) of 68Ga-SFB6-ZN01 PET/CT for detecting malignant lesions (primary and metastatic), using histopathology as the reference standard and/or clinical/imaging follow-up of at least 6 months as the composite reference standard.

  Up to 6 months post-imaging

Secondary Outcomes (8)

• Safety and Tolerability: Incidence of Adverse Events

  From injection to 72 hours post-injection

• Safety and Tolerability: Relationship of Adverse Events

  From injection to 72 hours post-injection

• Safety and Tolerability: Severity of Adverse Events

  From injection to 72 hours post-injection

• Biodistribution: Organ-Specific Standardized Uptake Values (SUV)

  At approximately 10, 60, 120, and 180 minutes post-injection

• Biodistribution: Time-Activity Curves

  From 0 to 3 hours post-injection (serial scans at 10, 60, 120, and 180 minutes)

Other Outcomes (1)

• Correlation of PET Parameters with Histopathological Features

  Up to 3 months post-imaging (when surgical or biopsy specimens are available)

Study Arms (1)

68Ga-SFB6-ZN01 PET/CT

EXPERIMENTAL

Participants receive a single intravenous injection of 68Ga-SFB6-ZN01 followed by whole-body PET/CT acquisition approximately 60 minutes post-injection.

Drug: 68Ga-SFB6-ZN01

Interventions

68Ga-SFB6-ZN01 DRUG

Single intravenous bolus injection of 68Ga-SFB6-ZN01 (target activity: 111-185 MBq) followed by whole-body PET/CT scan at 60 ± 10 minutes post-injection.

68Ga-SFB6-ZN01 PET/CT

Eligibility Criteria

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

You may qualify if:

• Voluntary written informed consent.
• Age ≥ 18 years, male or female.
• Clinically suspected or pathologically confirmed malignant solid tumor, or suspicion of recurrence after treatment.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.
• Life expectancy ≥ 6 months.
• Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use highly effective contraception from consent until 6 months after study agent administration.

You may not qualify if:

• Administration of any radionuclide within a period less than 10 physical half-lives before study agent injection.
• Concurrent participation in another interventional clinical trial involving an investigational drug or device.
• Known hypersensitivity to 68Ga-SFB6-ZN01 or any of its excipients.
• Inability to lie flat or remain still during PET/CT acquisition, or any contraindication to PET/CT.
• Pregnancy or breastfeeding.
• Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Related Publications (9)

• Quigley NG, Steiger K, Hoberuck S, Czech N, Zierke MA, Kossatz S, Pretze M, Richter F, Weichert W, Pox C, Kotzerke J, Notni J. PET/CT imaging of head-and-neck and pancreatic cancer in humans by targeting the "Cancer Integrin" alphavbeta6 with Ga-68-Trivehexin. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1136-1147. doi: 10.1007/s00259-021-05559-x. Epub 2021 Sep 24.

  PMID: 34559266 BACKGROUND

• Kimura RH, Wang L, Shen B, Huo L, Tummers W, Filipp FV, Guo HH, Haywood T, Abou-Elkacem L, Baratto L, Habte F, Devulapally R, Witney TH, Cheng Y, Tikole S, Chakraborti S, Nix J, Bonagura CA, Hatami N, Mooney JJ, Desai T, Turner S, Gaster RS, Otte A, Visser BC, Poultsides GA, Norton J, Park W, Stolowitz M, Lau K, Yang E, Natarajan A, Ilovich O, Srinivas S, Srinivasan A, Paulmurugan R, Willmann J, Chin FT, Cheng Z, Iagaru A, Li F, Gambhir SS. Evaluation of integrin alphavbeta6 cystine knot PET tracers to detect cancer and idiopathic pulmonary fibrosis. Nat Commun. 2019 Oct 14;10(1):4673. doi: 10.1038/s41467-019-11863-w.

  PMID: 31611594 BACKGROUND

• Altmann A, Sauter M, Roesch S, Mier W, Warta R, Debus J, Dyckhoff G, Herold-Mende C, Haberkorn U. Identification of a Novel ITGalphavbeta6-Binding Peptide Using Protein Separation and Phage Display. Clin Cancer Res. 2017 Aug 1;23(15):4170-4180. doi: 10.1158/1078-0432.CCR-16-3217. Epub 2017 May 3.

  PMID: 28468949 BACKGROUND

• Keat N, Kenny J, Chen K, Onega M, Garman N, Slack RJ, Parker CA, Lumbers RT, Hallett W, Saleem A, Passchier J, Lukey PT. A Microdose PET Study of the Safety, Immunogenicity, Biodistribution, and Radiation Dosimetry of 18F-FB-A20FMDV2 for Imaging the Integrin alphavbeta6. J Nucl Med Technol. 2018 Jun;46(2):136-143. doi: 10.2967/jnmt.117.203547. Epub 2018 Feb 2.

  PMID: 29438002 BACKGROUND

• Kimura RH, Iagaru A, Guo HH. Mini review of first-in-human integrin alphavbeta6 PET tracers. Front Nucl Med. 2023 Oct 9;3:1271208. doi: 10.3389/fnume.2023.1271208. eCollection 2023.

  PMID: 39355045 BACKGROUND

• Niu J, Li Z. The roles of integrin alphavbeta6 in cancer. Cancer Lett. 2017 Sep 10;403:128-137. doi: 10.1016/j.canlet.2017.06.012. Epub 2017 Jun 17.

  PMID: 28634043 BACKGROUND

• Chastney MR, Kaivola J, Leppanen VM, Ivaska J. The role and regulation of integrins in cell migration and invasion. Nat Rev Mol Cell Biol. 2025 Feb;26(2):147-167. doi: 10.1038/s41580-024-00777-1. Epub 2024 Sep 30.

  PMID: 39349749 BACKGROUND

• Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108.

  PMID: 35143424 BACKGROUND

• Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

  PMID: 38572751 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Yong He, MD, PhD

CONTACT

+86-27-67812698; heyong@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Images will be independently interpreted by at least two experienced nuclear medicine physicians who are blinded to all clinical information, including histopathological diagnosis, prior imaging findings, and patient history. Discrepancies will be resolved by consensus or a third blinded reader.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)