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

NCT ID: NCT07138716

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-10
• Study Completion Date: 2028-12-01

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.

Detailed Description

This clinical study investigates the diagnostic potential of 68Ga-DOTA-CCK-FS PET/CT, a novel radiopharmaceutical targeting the cholecystokinin-2 receptor (CCK-2R), in patients with medullary thyroid carcinoma (MTC) and other CCK-2R-expressing tumors. The research is led by Prof. Luo Yaping, Chief Physician at Peking Union Medical College Hospital (PUMCH), in collaboration with Prof. Liu Zhibo, a radiochemistry expert from Peking University. The trial will enroll 30-40 eligible patients with confirmed or suspected MTC (based on histopathology, elevated calcitonin/CEA levels, or MEN2 family history) or other CCK-2R-positive malignancies. Each participant will undergo 68Ga-DOTA-CCK-FS PET/CT, with comparative imaging (either 18F-FDG PET/CT for non-neuroendocrine tumors or 68Ga-DOTATATE PET/CT for neuroendocrine tumors) performed within 2 weeks. The study focuses on evaluating the tracer's sensitivity, specificity, and tumor-targeting efficiency through both visual and quantitative analyses (e.g., SUV measurements). Preclinical data suggest 68Ga-DOTA-CCK-FS offers superior tumor uptake and retention compared to existing probes, potentially enabling earlier detection and better therapeutic stratification for MTC, which often presents with aggressive metastasis and limited treatment options. PUMCH's Class IV Radioactive Drug License allows in-house production of this investigational tracer, addressing unmet clinical needs. Safety monitoring includes tracking minor injection-site reactions or radiation exposure (equivalent to a standard abdominal CT). Participants benefit from free advanced imaging and contribute to refining precision diagnostics for CCK-2R-driven cancers. Results may pave the way for future theranostic applications (e.g., 177Lu-labeled CCK-2R therapy).

Conditions

Medullary Thyroid Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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).

Group Type: OTHER

68Ga-DOTA-CCK-FS PET/CT

Intervention Type: 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 68Ga-DOTA-TATE PET/CT imaging

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

Group Type: OTHER

68Ga-DOTA-CCK-FS PET/CT

Intervention Type: 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.

Interventions

68Ga-DOTA-CCK-FS PET/CT

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age not limited (male or female).

2. 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).

3. Performance Status: Life expectancy ≥12 weeks.

4. Contraception: Willingness to use effective birth control (if applicable).

5. Consent: Signed informed consent and compliance with follow-up.

Exclusion Criteria

1. Severe hepatic/renal dysfunction (e.g., ALT/AST >3×ULN, Cr >2.0 mg/dL).

2. Pregnancy/lactation or planned pregnancy during the study.

3. Inability to lie still for PET/CT (e.g., severe claustrophobia).

4. 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).*

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Luo Yaping

OTHER

Sponsor Role: lead

Responsible Party

Luo Yaping

Medical Doctor (M.D.), Chief Physician, Professor, Assistant Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yaping LUO

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yaping Luo, MD

Role: CONTACT

luoyaping@live.com

86-010-69154716

Facility Contacts

Jiayue Li

Role: primary

xs@abscd.com

86-010-69156874

Other Identifiers

CCK-2R

Identifier Type: -

Identifier Source: org_study_id