Ovarian CancerNCT06232122
Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer
A study testing 68Ga-FAPI-46 and 18F-FDG in people with Ovarian Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
A prospective cohort imaging study in a single institution to evaluate 68Ga- FAPI-46 and 18F-FDG PET/CT imaging for detecting recurrent tumor lesions in patients of ovarian cancer with CA125 elevation from complete response after therapy Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- 68Ga-FAPI-46 and 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2022to 31 Jul 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 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven ovarian cancer with complete response after therapy
- Age between 30 and 80
- Elevation of serum CA125 value above the normal range (>35 U/mL) or doubling of serum CA125 value within the normal range
- ECOG performance status grade 0 or 1 and willing to receive further therapy if disease recurrence is confirmed
- Willing to enter this prospective study with signed informed consent form
Who cannot join
- Patients with history of other malignancy
- Patients who are pregnant or lactating
- Patients with fasting fingerstick glucose level higher than 200 mg/dl
- Known allergic reactions to components of the radiopharmaceutical solutions for intravenous injection for 68Ga-FAPI-46 or 18F-FDG imaging studies
- Patients who are incapable of lying still for 30 minutes to receive the PET/CT scan as assessed by investigators
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
Chang-Gung Memorial Hospital, Linkou Branch
Taoyuan City
Feng-Yuan Liu, (+886)975365782, billiu@cgmh.org.tw
About this study
Official title: Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer With CA125 Elevation From Complete Response After Therapy
A prospective cohort imaging study in a single institution to evaluate 68Ga- FAPI-46 and 18F-FDG PET/CT imaging for detecting recurrent tumor lesions in patients of ovarian cancer with CA125 elevation from complete response after therapy
Read the detailed description
Ovarian cancer is the eighth most common cancer worldwide in females and usually diagnosed at an advanced stage. Serum cancer antigen 125 (CA125) is widely used in ovarian cancer. An elevation in CA125 levels can precede a clinically apparent recurrence by 3 to 6 months and 18F-FDG PET/CT can modify management in approximately half of these patients. However. 18F-FDG PET/CT may yield false negative results. 68Ga-FAPI-46 PET/CT shows potential here. This study is to assess the diagnostic performances of 68Ga-FAPI-46 and 18F-FDG PET/CT for ovarian cancer recurrence in patients with CA125 elevation from complete response after therapy.
- Conditions
- Ovarian Cancer
- Being tested
- 68Ga-FAPI-46, 18F-FDG
- Keywords
- 68Ga-FAPI-46, 18F-FDG, CA-125
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-46Diagnostic test
Also called 68Ga-fibroblast activating protein inhibitors
Intravenous injection of one dosage of 2 mCi 68Ga-FAPI-46
18F-FDGDiagnostic test
Also called 18F-fluorodeoxyglucose
Intravenous injection of one dosage of 5-10mCi 18F-FDG
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI ,PET/CT | Experimental | Inject 68Ga-FAPI and then perform PET/CT scan. Receives: Diagnostic Test: 68Ga-FAPI-46; Diagnostic Test: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performances of 68Ga-FAPI and 18F-FDG PET/CT for ovarian cancer recurrence after one year from PET/CT imaging in Per-Protocol Analysis Dataset
Diagnostic performance is defined as the AUC value of ROC curve (sensitivity against 1-specificity at different PET/CT imaging scores ranged from 1 to 4).
Cancer recurrence is defined by pathological or imaging evidence up to one year after 68Ga-FAPI-46 PET/CT study.
Measured: 2 months for individual participants to complete all visits
Secondary outcomes (2)
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the duration (months) from the initiation of further therapy to disease progression assessed by Gynecological Cancer Intergroup (GCIG) guideline which incorporates both RECIST 1.1 and CA125 or to death.
Measured: 5 years
Overall Survival (OS)
Overall survival (OS) is defined as the duration (months) from the 68Ga-FAPI-46 PET/CT study to death.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Aug 2022
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng-Yuan Liu, MD, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232122
- Sponsor's protocol ID
- 202102208A0
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer With CA125 Elevation From Complete Response After Therapy
- ClinicalTrials.gov ID
- NCT06232122
- Acronym / sponsor ID
- 202102208A0
- Conditions
- Ovarian Cancer
- Keywords
- 68Ga-FAPI-46, 18F-FDG, CA-125
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 30 Jan 2024 (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.
A prospective cohort imaging study in a single institution to evaluate 68Ga- FAPI-46 and 18F-FDG PET/CT imaging for detecting recurrent tumor lesions in patients of ovarian cancer with CA125 elevation from complete response after therapy
Detailed description
Ovarian cancer is the eighth most common cancer worldwide in females and usually diagnosed at an advanced stage. Serum cancer antigen 125 (CA125) is widely used in ovarian cancer. An elevation in CA125 levels can precede a clinically apparent recurrence by 3 to 6 months and 18F-FDG PET/CT can modify management in approximately half of these patients. However. 18F-FDG PET/CT may yield false negative results. 68Ga-FAPI-46 PET/CT shows potential here. This study is to assess the diagnostic performances of 68Ga-FAPI-46 and 18F-FDG PET/CT for ovarian cancer recurrence in patients with CA125 elevation from complete response after therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI ,PET/CT | Experimental | Diagnostic Test: 68Ga-FAPI-46, Diagnostic Test: 18F-FDGInject 68Ga-FAPI and then perform PET/CT scan. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically proven ovarian cancer with complete response after therapy
- Age between 30 and 80
- Elevation of serum CA125 value above the normal range (>35 U/mL) or doubling of serum CA125 value within the normal range
- ECOG performance status grade 0 or 1 and willing to receive further therapy if disease recurrence is confirmed
- Willing to enter this prospective study with signed informed consent form
Key exclusion criteria (5 listed)
- Patients with history of other malignancy
- Patients who are pregnant or lactating
- Patients with fasting fingerstick glucose level higher than 200 mg/dl
- Known allergic reactions to components of the radiopharmaceutical solutions for intravenous injection for 68Ga-FAPI-46 or 18F-FDG imaging studies
- Patients who are incapable of lying still for 30 minutes to receive the PET/CT scan as assessed by investigators
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-FAPI-46Also: 68Ga-fibroblast activating protein inhibitorsIntravenous injection of one dosage of 2 mCi 68Ga-FAPI-46 | Diagnostic test | 68Ga-FAPI ,PET/CT |
| 18F-FDGAlso: 18F-fluorodeoxyglucoseIntravenous injection of one dosage of 5-10mCi 18F-FDG | Diagnostic test | 68Ga-FAPI ,PET/CT |
Primary outcome
Diagnostic performances of 68Ga-FAPI and 18F-FDG PET/CT for ovarian cancer recurrence after one year from PET/CT imaging in Per-Protocol Analysis Dataset
Time frame: 2 months for individual participants to complete all visits
Diagnostic performance is defined as the AUC value of ROC curve (sensitivity against 1-specificity at different PET/CT imaging scores ranged from 1 to 4). Cancer recurrence is defined by pathological or imaging evidence up to one year after 68Ga-FAPI-46 PET/CT study.
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 5 years
Overall Survival (OS)
Time frame: 5 years
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 30 Jan 2024.
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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 68Ga-FAPI-46 and 18F-FDG in people with Ovarian Cancer, run by Chang Gung Memorial Hospital 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 5 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 30 Jan 2024. 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 Feng-Yuan Liu (0975365782, billliu@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performances of 68Ga-FAPI and 18F-FDG PET/CT for ovarian cancer recurrence after one year from PET/CT imaging in Per-Protocol Analysis Dataset (time frame: 2 months for individual participants to complete all visits). 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 30 Jan 2024.