Colorectal Cancer RecurrentGa-68-FAPI-46NCT06769828
Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA
A study testing Ga-68-FAPI-46 in people with Colorectal Cancer Recurrent, run by Koo Foundation Sun Yat-Sen Cancer Center at 1 site in Taiwan.
Trial summary
This single-center, phase II clinical trial investigates the diagnostic efficacy of Ga-68-FAPI-46 PET scans in detecting colorectal cancer (CRC) recurrence during post-treatment surveillance, particularly in patients with elevated serum carcinoembryonic antigen (CEA). Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Colorectal Cancer Recurrent
- What is being tested?
- Ga-68-FAPI-46
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2025to 14 Apr 2026
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20 years old
- The surgical intervention for colorectal cancer aims for curative resection, with the goal of achieving a disease-free status that persists for six months or more, as assessed clinically and through imaging studies.
- Elevated serum CEA levels:
- Exceeding the laboratory's normal range (5 ng/ml) or, but not surpassing 13 ng/ml; using the individual's post-surgery +/- adjuvant chemotherapy or targeted therapy minimum value as a baseline, a consecutive increase of more than 10% for two times or as determined by the attending physician suggests suspicion of recurrence.
- Already performed or scheduled for FDG PET scanning examination. (5) Able to lie flat for at least 30 minutes.
- Signing the subject consent form.
- ECOG grade 0-2.
- The timing of F-18-FDG usage in this trial follows the " 2023 - Colorectal Cancer Treatment Principles" of our institution.
Who cannot join
- pregnant woman and breastfeeding women
- severe renal impairment (eGRF< 30ml/min)
- Known or suspected allergy to radiopharmaceuticals
- Simultaneously or previously diagnosed with malignant tumors other than colorectal cancer.
- Inability to undergo the necessary PET scan procedure
- Refusal or unwillingness to sign the informed consent form
- Severe medical conditions (severe disabilities, mental disorders)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Beitou, 1125019
Yu Yi Huang, MD, +886 28970011 ext. 1121, yuyi@kfsyscc.org
Cheng Ling Yang, B.Rad., +886 28970011 ext. 1167, androgyny@kfsyscc.org
About this study
Official title: Diagnostic Performances of Ga-68-FAPI-46 PET in CRC Patients with Rising Serum CEA During the Post-treatment Surveillance
This single-center, phase II clinical trial investigates the diagnostic efficacy of Ga-68-FAPI-46 PET scans in detecting colorectal cancer (CRC) recurrence during post-treatment surveillance, particularly in patients with elevated serum carcinoembryonic antigen (CEA). The study compares the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET with the conventional F-18-FDG PET scans, aiming to enhance recurrence detection in CRC patients who underwent curative surgery. Thirty participants will be enrolled and monitored through imaging studies and clinical follow-up.
Read the detailed description
Colorectal cancer (CRC) is one of the leading causes of cancer-related mortality, with a significant recurrence rate following curative surgery, particularly in stages II and III. Early detection of asymptomatic recurrence is critical for initiating salvage treatment. Serum CEA elevation is a marker for recurrence, necessitating advanced imaging tools for precise localization.
This study evaluates the use of Ga-68-FAPI-46, a novel imaging agent targeting fibroblast activation protein (FAP), which is overexpressed in the tumor stroma. Ga-68-FAPI-46 demonstrates higher tumor uptake and faster clearance from normal tissues compared to F-18-FDG, offering a potential diagnostic advantage. Participants will undergo both F-18-FDG PET and Ga-68-FAPI-46 PET scans, with lesion detection validated through pathology or clinical follow-up.
The trial aims to determine the diagnostic performance of Ga-68-FAPI-46 PET in terms of sensitivity, specificity, positive predictive value, and negative predictive value, using the McNemar test for statistical comparison. The study also emphasizes participant safety and data protection, adhering to Good Clinical Practice (GCP) guidelines.
- Conditions
- Colorectal Cancer Recurrent
- Being tested
- Ga-68-FAPI-46
- Keywords
- Ga-68-FAPI-46 PET/CT, Colorectal cancer (CRC)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68-FAPI-46Drug
Also called PET/CT
Ga-68-FAPI-46 PET scan in colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Ga-68-FAPI-46 PET scan in colorectal cancer | Experimental | Participants in this arm will undergo a Ga-68-FAPI-46 PET scan within 2-14 days after their F-18-FDG PET scan. Ga-68-FAPI-46 will be administered via intravenous injection at a dose of 1.8-2.2 MBq per kilogram of body weight, with a maximum dose of 200 MBq. The scan will be performed 30-90 minutes after injection. This study aims to evaluate the diagnostic performance of Ga-68-FAPI-46 PET in detecting colorectal cancer recurrence in patients with elevated serum carcinoembryonic antigen (CEA), compared to F-18-FDG PET. Receives: Drug: Ga-68-FAPI-46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, Specificity, and Accuracy of Ga-68-FAPI-46 PET for CRC Recurrence Detection
Evaluate the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET in detecting colorectal cancer recurrence. Pathological results will be used as the reference standard where available, or clinical follow-up will be used in cases where tissue sampling is not feasible.
Measured: Within 6 months of PET imaging.
Comparison of Ga-68-FAPI-46 PET and FDG PET in CRC Recurrence Detection
Compare the diagnostic performance of Ga-68-FAPI-46 PET and F-18-FDG PET in detecting colorectal cancer recurrence, including sensitivity, specificity, and accuracy.
Measured: Within 6 months of PET imaging.
Secondary outcomes (1)
Clinical Impact of Ga-68-FAPI-46 PET on Management Decisions
Evaluate the impact of Ga-68-FAPI-46 PET imaging on clinical decision-making through a questionnaire completed by the principal investigator before and after receiving the PET results. The questionnaire assesses changes in diagnosis, treatment planning, and patient management.
Measured: Immediately after completion of PET imaging and report review.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion14 Apr 2026 (estimated)
- Study completion14 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer RecurrentStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koo Foundation Sun Yat-Sen Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769828
- Sponsor's protocol ID
- KF-FAPI46-001
- Acronym
- Ga-68-FAPI-46
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performances of Ga-68-FAPI-46 PET in CRC Patients with Rising Serum CEA During the Post-treatment Surveillance
- ClinicalTrials.gov ID
- NCT06769828
- Acronym / sponsor ID
- Ga-68-FAPI-46 / KF-FAPI46-001
- Conditions
- Colorectal Cancer Recurrent
- Keywords
- Ga-68-FAPI-46 PET/CT, Colorectal cancer (CRC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Koo Foundation Sun Yat-Sen Cancer CenterUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 14 Apr 2026 (estimated)
- Study completion
- 14 Apr 2026 (estimated)
- First posted
- 10 Jan 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 single-center, phase II clinical trial investigates the diagnostic efficacy of Ga-68-FAPI-46 PET scans in detecting colorectal cancer (CRC) recurrence during post-treatment surveillance, particularly in patients with elevated serum carcinoembryonic antigen (CEA). The study compares the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET with the conventional F-18-FDG PET scans, aiming to enhance recurrence detection in CRC patients who underwent curative surgery. Thirty participants will be enrolled and monitored through imaging studies and clinical follow-up.
Detailed description
Colorectal cancer (CRC) is one of the leading causes of cancer-related mortality, with a significant recurrence rate following curative surgery, particularly in stages II and III. Early detection of asymptomatic recurrence is critical for initiating salvage treatment. Serum CEA elevation is a marker for recurrence, necessitating advanced imaging tools for precise localization.
This study evaluates the use of Ga-68-FAPI-46, a novel imaging agent targeting fibroblast activation protein (FAP), which is overexpressed in the tumor stroma. Ga-68-FAPI-46 demonstrates higher tumor uptake and faster clearance from normal tissues compared to F-18-FDG, offering a potential diagnostic advantage. Participants will undergo both F-18-FDG PET and Ga-68-FAPI-46 PET scans, with lesion detection validated through pathology or clinical follow-up.
The trial aims to determine the diagnostic performance of Ga-68-FAPI-46 PET in terms of sensitivity, specificity, positive predictive value, and negative predictive value, using the McNemar test for statistical comparison. The study also emphasizes participant safety and data protection, adhering to Good Clinical Practice (GCP) guidelines.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ga-68-FAPI-46 PET scan in colorectal cancer | Experimental | Drug: Ga-68-FAPI-46Participants in this arm will undergo a Ga-68-FAPI-46 PET scan within 2-14 days after their F-18-FDG PET scan. Ga-68-FAPI-46 will be administered via intravenous injection at a dose of 1.8-2.2 MBq per kilogram of body weight, with a maximum dose of 200 MBq. The scan will be performed 30-90 minutes after injection. This study aims to evaluate the diagnostic performance of Ga-68-FAPI-46 PET in detecting colorectal cancer recurrence in patients with elevated serum carcinoembryonic antigen (CEA), compared to F-18-FDG PET. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 20 years old
- The surgical intervention for colorectal cancer aims for curative resection, with the goal of achieving a disease-free status that persists for six months or more, as assessed clinically and through imaging studies.
- Elevated serum CEA levels:
- Exceeding the laboratory's normal range (5 ng/ml) or, but not surpassing 13 ng/ml; using the individual's post-surgery +/- adjuvant chemotherapy or targeted therapy minimum value as a baseline, a consecutive increase of more than 10% for two times or as determined by the attending physician suggests suspicion of recurrence.
- Already performed or scheduled for FDG PET scanning examination. (5) Able to lie flat for at least 30 minutes.
Key exclusion criteria (7 listed)
- pregnant woman and breastfeeding women
- severe renal impairment (eGRF< 30ml/min)
- Known or suspected allergy to radiopharmaceuticals
- Simultaneously or previously diagnosed with malignant tumors other than colorectal cancer.
- Inability to undergo the necessary PET scan procedure
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 |
|---|---|---|
| Ga-68-FAPI-46Also: PET/CTGa-68-FAPI-46 PET scan in colorectal cancer | Drug | Ga-68-FAPI-46 PET scan in colorectal cancer |
Primary outcome
Sensitivity, Specificity, and Accuracy of Ga-68-FAPI-46 PET for CRC Recurrence Detection
Time frame: Within 6 months of PET imaging.
Evaluate the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET in detecting colorectal cancer recurrence. Pathological results will be used as the reference standard where available, or clinical follow-up will be used in cases where tissue sampling is not feasible.
Comparison of Ga-68-FAPI-46 PET and FDG PET in CRC Recurrence Detection
Time frame: Within 6 months of PET imaging.
Compare the diagnostic performance of Ga-68-FAPI-46 PET and F-18-FDG PET in detecting colorectal cancer recurrence, including sensitivity, specificity, and accuracy.
1 secondary outcome
Clinical Impact of Ga-68-FAPI-46 PET on Management Decisions
Time frame: Immediately after completion of PET imaging and report review.
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 22 Jan 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ga-68-FAPI-46 in people with Colorectal Cancer Recurrent, run by Koo Foundation Sun Yat-Sen Cancer Center at 1 site in Taiwan.
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 8 inclusion and 7 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 22 Jan 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 Taiwan. 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 Yu Yi Huang, MD (+886 28970011 ext. 1121, yuyi@kfsyscc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, Specificity, and Accuracy of Ga-68-FAPI-46 PET for CRC Recurrence Detection (time frame: Within 6 months of PET imaging.). The study lists 2 primary outcomes in all. 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 22 Jan 2025.