Research on the Application of 68Ga-DOTA-CCK-FS PET/CT in MTC

NCT07138716 | Recruiting

• 1 other identifier: CCK-2R
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores the clinical application of 68Ga-DOTA-CCK-FS PET/CT in detecting cholecystokinin-2 receptor (CCK-2R)-positive tumors, particularly medullary thyroid cancer (MTC) and other malignancies. Led by Prof. Luo Yaping (PUMCH Nuclear Medicine) and Prof. Liu Zhibo (Peking University, radiochemistry expert), the trial will enroll 30-40 patients to compare 68Ga-DOTA-CCK-FS imaging with standard PET/CT (e.g., 18F-FDG or 68Ga-DOTATATE). The novel tracer shows higher tumor uptake and retention in preclinical studies, potentially improving diagnosis and treatment guidance for aggressive, CCK-2R-expressing cancers. The study leverages PUMCH's Class IV Radioactive Drug License for advanced radiopharmaceutical development. Risks are minimal (diagnostic radiation dose only), and participants receive free imaging assessments. Results aim to refine precision diagnostics for MTC and related tumors.

Conditions

Medullary Thyroid Carcinoma

Keywords

MTC; CCK-2R; PET/CT

Outcome Measures

Primary Outcomes (1)

• diagnostic performance

  Diagnostic performance of 68Ga-DOTA-CCK-FS PET/CT in detecting CCK-2R-positive tumors, as measured by sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy using histopathology or clinical follow-up as the reference standard.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Comparative efficacy

  through study completion, an average of 1 year

• Correlation

  through study completion, an average of 1 year

• Safety profile

  through study completion, an average of 1 year

Other Outcomes (1)

• Exploratory Outcomes

  through study completion, an average of 1 year

Study Arms (2)

68Ga-DOTA-CCK-FS and 68Ga-DOTA-TATE PET/CT imaging

OTHER

For the patients with neuroendocrine neoplasm. Intravenous administration of 1.8-2.2 MBq/kg (0.05-0.06 mCi/kg) of each radiotracer within one week. For 68Ga-DOTA-CCK-FS, imaging begins 60±5 minutes post-injection to evaluate cholecystokinin receptor (CCK-R) expression, while 68Ga-DOTA-TATE scanning starts at 45-60 minutes post-injection for somatostatin receptor (SSTR) assessment, both using a time-of-flight PET/CT system with low-dose CT (120 kVp, 30-50 mAs) for attenuation correction followed by whole-body PET acquisition (2-3 min/bed position). Images are reconstructed using OSEM algorithms

Diagnostic Test: 68Ga-DOTA-CCK-FS PET/CT

68Ga-DOTA-CCK-FS and 18F-FDG PET/CT imaging

OTHER

For the patients with non-neuroendocrine neoplasm. 68Ga-DOTA-CCK-FS PET/CT was perfomed 60±5 minutes post-injection of 1.8-2.2 MBq/kg (0.05-0.06 mCi/kg) tracer. The 18F-FDG PET/CT imaging protocol requires patients to fast for at least 6 hours and maintain blood glucose levels \<150-200 mg/dL prior to intravenous administration of 3.7-5.2 MBq/kg (0.1-0.14 mCi/kg) of 18F-FDG. After a 60±5 minute uptake period , imaging is performed on a time-of-flight PET/CT system (2-3 minutes per bed position, covering skull base to mid-thigh).

Diagnostic Test: 68Ga-DOTA-CCK-FS PET/CT

Interventions

68Ga-DOTA-CCK-FS PET/CT DIAGNOSTIC_TEST

For 68Ga-DOTA-CCK-FS, imaging begins 60±5 minutes post-injection to evaluate cholecystokinin receptor (CCK-R) expression, using a time-of-flight PET/CT system with low-dose CT (120 kVp, 30-50 mAs) for attenuation correction followed by whole-body PET acquisition (2-3 min/bed position). Images are reconstructed using OSEM algorithms.

68Ga-DOTA-CCK-FS and 18F-FDG PET/CT imaging; 68Ga-DOTA-CCK-FS and 68Ga-DOTA-TATE PET/CT imaging

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age not limited (male or female).
• Diagnosis:Confirmed or suspected medullary thyroid carcinoma (MTC) based on:
• Fine-needle aspiration (FNA) cytology/histopathology, or Elevated serum calcitonin/CEA with thyroid nodule(s), or Clinical/hereditary suspicion (e.g., MEN2 syndrome), or Other histologically confirmed CCK-2R-positive tumors (e.g., neuroendocrine tumors, gastric/ovarian cancers).
• Performance Status: Life expectancy ≥12 weeks.
• Contraception: Willingness to use effective birth control (if applicable).
• Consent: Signed informed consent and compliance with follow-up.

You may not qualify if:

• Severe hepatic/renal dysfunction (e.g., ALT/AST \>3×ULN, Cr \>2.0 mg/dL).
• Pregnancy/lactation or planned pregnancy during the study.
• Inability to lie still for PET/CT (e.g., severe claustrophobia).
• Concurrent conditions compromising study safety (investigator's judgment).
• \*Note: CCK-2R positivity may be confirmed via prior immunohistochemistry (if available) or inferred from tumor type (e.g., MTC).\*

Sponsors & Collaborators

• Luo Yaping: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Medullary

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Study Officials

• Yaping LUO

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaping Luo, MD

CONTACT

86-010-69154716; luoyaping@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor (M.D.), Chief Physician, Professor, Assistant Director

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: August 24, 2025
• Study Start: May 10, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)