Medullary Thyroid CarcinomaNCT07138716
Research on the Application of 68Ga-DOTA-CCK-FS PET/CT in MTC
A study testing 68Ga-DOTA-CCK-FS PET/CT in people with Medullary Thyroid Carcinoma, run by Luo Yaping at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medullary Thyroid Carcinoma
- What is being tested?
- 68Ga-DOTA-CCK-FS PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Jiayue Li, 86-010-69156874, xs@abscd.com
About this study
Official title: Application Study of 68Ga-DOTA-CCK-FS PET/CT in Medullary Thyroid Carcinoma (MTC) and Various Other Tumors With Positive Expression of Cholecystokinin-2 Receptor (CCK-2R)
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.
Read the 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
- Being tested
- 68Ga-DOTA-CCK-FS PET/CT
- Keywords
- MTC, CCK-2R, PET/CT
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTA-CCK-FS PET/CTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Diagnostic Test: 68Ga-DOTA-CCK-FS PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Comparative efficacy
Comparative efficacy of 68Ga-DOTA-CCK-FS PET/CT versus standard imaging (18F-FDG PET/CT for non-neuroendocrine tumors or 68Ga-DOTATATE PET/CT for neuroendocrine tumors) in:
Tumor detection rate (number and location of lesions)
Target-to-background ratio (TBR) based on SUVmax (tumor vs. liver/blood pool/muscle)
Measured: through study completion, an average of 1 year
Correlation
Correlation between 68Ga-DOTA-CCK-FS uptake (SUVmax/SUVpeak) and Serum tumor markers (e.g., calcitonin, CEA for MTC); Tumor differentiation status (if histopathology is available)
Measured: through study completion, an average of 1 year
Safety profile
Safety profile of 68Ga-DOTA-CCK-FS, assessed by Incidence of adverse events (AEs) related to tracer administration and Radiation dosimetry estimates
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start10 May 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medullary Thyroid CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luo Yaping
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Sponsor-investigator, Luo Yaping, Peking Union Medical College Hospital
- Investigators
- Yaping LUO, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138716
- Sponsor's protocol ID
- CCK-2R
- Status last verified
- Aug 2025
- First submitted
- 7 May 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient privacy regulations and institutional policies, individual participant data (IPD) from this study will not be publicly available. The data contain sensitive clinical and genetic information that could compromise participant confidentiality. Additionally, Chinese data protection laws and hospital ethical guidelines restrict the open sharing of identifiable medical data. However, aggregated results (e.g., group-level imaging findings, statistical analyses) will be published in peer-reviewed journals. Researchers may request limited, anonymized datasets for collaborative purposes, subject to approval by the Peking Union Medical College Hospital (PUMCH) Ethics Committee and compliance with data transfer agreements.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Study of 68Ga-DOTA-CCK-FS PET/CT in Medullary Thyroid Carcinoma (MTC) and Various Other Tumors With Positive Expression of Cholecystokinin-2 Receptor (CCK-2R)
- ClinicalTrials.gov ID
- NCT07138716
- Acronym / sponsor ID
- CCK-2R
- Conditions
- Medullary Thyroid Carcinoma
- Keywords
- MTC, CCK-2R, PET/CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Luo YapingUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 10 May 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTA-CCK-FS and 68Ga-DOTA-TATE PET/CT imaging | Other | Diagnostic Test: 68Ga-DOTA-CCK-FS PET/CTFor 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 |
| 68Ga-DOTA-CCK-FS and 18F-FDG PET/CT imaging | Other | Diagnostic Test: 68Ga-DOTA-CCK-FS PET/CTFor 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-DOTA-CCK-FS PET/CTFor 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. | Diagnostic test | 68Ga-DOTA-CCK-FS and 18F-FDG PET/CT imaging, 68Ga-DOTA-CCK-FS and 68Ga-DOTA-TATE PET/CT imaging |
Primary outcome
diagnostic performance
Time frame: through study completion, an average of 1 year
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.
3 secondary outcomes
Comparative efficacy
Time frame: through study completion, an average of 1 year
Correlation
Time frame: through study completion, an average of 1 year
Safety profile
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No. Due to patient privacy regulations and institutional policies, individual participant data (IPD) from this study will not be publicly available. The data contain sensitive clinical and genetic information that could compromise participant confidentiality. Additionally, Chinese data protection laws and hospital ethical guidelines restrict the open sharing of identifiable medical data. However, aggregated results (e.g., group-level imaging findings, statistical analyses) will be published in peer-reviewed journals. Researchers may request limited, anonymized datasets for collaborative purposes, subject to approval by the Peking Union Medical College Hospital (PUMCH) Ethics Committee and compliance with data transfer agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yaping LUO principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-DOTA-CCK-FS PET/CT in people with Medullary Thyroid Carcinoma, run by Luo Yaping at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaping Luo, MD (86-010-69154716, luoyaping@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic performance (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.