Malignant Tumors99mTc；FAPI；mCiNCT06753513
Clinical Application of 99mTc-FDPH46 SPECT/CT Imaging in Malignant Solid Tumor: a Prospective Exploratory Study
An observational study of Malignant Tumors and Solid Tumor Malignancy, run by Zhejiang University at 1 site in China.
Trial summary
The goal of this observational study aims to preliminarily evaluate the diagnostic efficacy of 99mTc-FDPH46 SPECT/CT in malignant solid tumors (compared to the pathological gold standard). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Tumors, Solid Tumor Malignancy
- What is being tested?
- 99mTc-FDPH46 SPECT/CT Imaging
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2024to 31 Dec 2026
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are clinically suspected or diagnosed with malignant solid tumors.
Who may be able to join
- Patients who are clinically suspected or diagnosed with malignant solid tumors.
- Ages between 18 to 80 years old.
- Stable vital signs, ECOG score of 0-2, capable of tolerating and cooperating with the 99mTc-FDPH46 SPECT/CT examination.
- Subjects who are willing to undergo the 99mTc-FDPH46 SPECT/CT examination and have signed the informed consent form.
Who cannot join
- Those who can not understand, comply with the research protocol or are unable to sign the informed consent form.
- Contraindications for SPECT imaging (including pregnant women, nursing women, women of childbearing age with recent plans to conceive, etc.).
- Unstable vital signs, ECOG score >2, unable to tolerate or cooperate with the 99mTc-FDPH46 SPECT/CT examination process.
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
No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province, China.
Hangzhou, Zhejiang, 310000
Zhang Jun, +(86)15088608182, 1505156@zju.edu.cn
About this study
The goal of this observational study aims to preliminarily evaluate the diagnostic efficacy of 99mTc-FDPH46 SPECT/CT in malignant solid tumors (compared to the pathological gold standard). The main questions it aims to answer are:
- What is the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors, compared to the pathological gold standard?
- What is the biodistribution, tumor uptake and safety of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors?
Participant Will:
- Patients with clinically suspected or diagnosed malignant solid tumors who are willing to undergo 99mTc-FDPH46 SPECT/CT examination and sign an informed consent form.
Read the detailed description
Patients who are clinically assessed as suspected or diagnosed with malignant solid tumors will receive an intravenous injection of 20-25mCi of 99mTc-FDPH46. Whole-body planar scintigraphy will be performed at 10, 30, 90, 150, and 240 minutes post-injection to obtain dynamic biodistribution images. Additionally, 99mTc-FDPH46 SPECT/CT imaging will be conducted 60-90 minutes after the intravenous injection to acquire both whole-body planar scintigraphy and SPECT/CT tomographic fusion images. After the scans are completed, patients will be observed in the waiting room for 1 hour before they are allowed to return.During the follow-up visit after the examination, the researchers will collect the patients' clinical information and any changes in symptoms, and record them in the medical records. All subjects will be followed up once on the same day after the SPECT/CT scan and again one week later.
- Conditions
- Malignant Tumors, Solid Tumor Malignancy
- Being tested
- 99mTc-FDPH46 SPECT/CT Imaging
- Keywords
- 99mTc, FDPH46, SPECT, Malignant Solid Tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-FDPH46 SPECT/CT ImagingOther
99mTc-FDPH46 SPECT/CT Imaging
| Study group | Role | What they receive |
|---|---|---|
| Patient Self-Control | Patient Self-Control Receives: Other: 99mTc-FDPH46 SPECT/CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared with the pathological gold standard, assess the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors.
Using the pathological gold standard as a reference, the sensitivity, specificity, positive predictive value, and negative predictive value of 99mTc-FDPH46 in patients with malignant solid tumors were evaluated. The consistency between the two diagnostic methods was assessed by Kappa analysis, thereby determining the diagnostic efficacy of 99mTc-FDPH46 in patients with malignant solid tumors.
Measured: 2024.12-2026.10
Secondary outcomes (1)
Assess the safety, biodistribution, and tumor uptake of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors.
Assess the safety of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors, recording any adverse reactions such as nausea, vomiting, and damage to liver and kidney functions; meanwhile, use the standardized uptake value (SUV) for a quantitative analysis of the tracer's biodistribution and tumor uptake in the patients' bodies.
Measured: 2024.12-2026.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start28 Dec 2024 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University
- Responsible party
- Principal investigator, Zhang jun, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753513
- Sponsor's protocol ID
- IIT20240134C-R1
- Acronym
- 99mTc；FAPI；mCi
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ruan Q, Feng J, Jiang Y, Zhang X, Duan X, Wang Q, Yin G, Xiao D, Zhang J. Preparation and Bioevaluation of 99mTc-Labeled FAP Inhibitors as Tumor Radiotracers to Target the Fibroblast Activation Protein. Mol Pharm. 2022 Jan 3;19(1):160-171. doi: 10.1021/acs.molpharmaceut.1c00712. Epub 2021 Dec 14.
PubMed 34904839Ruan Q, Zhou C, Wang Q, Kang F, Jiang Y, Li G, Feng J, Zong S, Zhang J, Wang J. A Simple Kit Formulation for Preparation and Exploratory Human Studies of a Novel 99mTc-Labeled Fibroblast Activation Protein Inhibitor Tracer for Imaging of the Fibroblast Activation Protein in Cancers. Mol Pharm. 2023 Jun 5;20(6):2942-2950. doi: 10.1021/acs.molpharmaceut.2c01094. Epub 2023 Apr 21.
PubMed 37083360Ruan Q, Wang Q, Jiang Y, Feng J, Yin G, Zhang J. Synthesis and Evaluation of 99mTc-Labeled FAP Inhibitors with Different Linkers for Imaging of Fibroblast Activation Proteins in Tumors. J Med Chem. 2023 Apr 13;66(7):4952-4960. doi: 10.1021/acs.jmedchem.2c02062. Epub 2023 Mar 27.
PubMed 36972467Ruan Q, Ding D, Diao L, Feng J, Yin G, Jiang Y, Wang Q, Han P, Jiang J, Zhang J. Synthesis and Preclinical Evaluation of Novel 99mTc-Labeled FAPI-46 Derivatives with Significant Tumor Uptake and Improved Tumor-to-Nontarget Ratios. J Med Chem. 2024 Feb 22;67(4):3190-3202. doi: 10.1021/acs.jmedchem.4c00031. Epub 2024 Feb 6.
PubMed 38320123Lindner T, Altmann A, Kramer S, Kleist C, Loktev A, Kratochwil C, Giesel F, Mier W, Marme F, Debus J, Haberkorn U. Design and Development of 99mTc-Labeled FAPI Tracers for SPECT Imaging and 188Re Therapy. J Nucl Med. 2020 Oct;61(10):1507-1513. doi: 10.2967/jnumed.119.239731. Epub 2020 Mar 13.
PubMed 32169911Liu Y, Zhang Q, Zhang Y, Wang J, Wu Y, Yang G, Shi J, Wang F, Xu Z, Jing H. 99mTc-Labeled FAPI SPECT Imaging in Idiopathic Pulmonary Fibrosis: Preliminary Results. Pharmaceuticals (Basel). 2023 Oct 9;16(10):1434. doi: 10.3390/ph16101434.
PubMed 37895905Luo X, Zhang Z, Cheng C, Wang T, Fang D, Zuo C, Yuan G, Li R, Li X. SPECT Imaging with Tc-99m-Labeled HYNIC-FAPI-04 to Extend the Differential Time Window in Evaluating Tumor Fibrosis. Pharmaceuticals (Basel). 2023 Mar 10;16(3):423. doi: 10.3390/ph16030423.
PubMed 36986521Jiang Y, Tian Y, Feng B, Zhao T, Du L, Yu X, Zhao Q. A novel molecular imaging probe [99mTc]Tc-HYNIC-FAPI targeting cancer-associated fibroblasts. Sci Rep. 2023 Mar 6;13(1):3700. doi: 10.1038/s41598-023-30806-6.
PubMed 36879039Ma M, Yang G, Zhao M, Liu Y, Ge X, Jia B, Gao S. Synthesis and Preliminary Study of 99mTc-Labeled HYNIC-FAPi for Imaging of Fibroblast Activation Proteins in Tumors. Mol Pharm. 2024 Feb 5;21(2):735-744. doi: 10.1021/acs.molpharmaceut.3c00886. Epub 2024 Jan 9.
PubMed 38193393Jia X, Li X, Jia B, Yang Y, Wang Y, Liu Y, Ji T, Xie X, Yao Y, Qiu G, Deng H, Zhu Z, Chen S, Yang A, Gao R. The role of [99mTc]Tc-HFAPi SPECT/CT in patients with malignancies of digestive system: first clinical experience. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1228-1239. doi: 10.1007/s00259-022-06068-1. Epub 2022 Dec 7.
PubMed 36477400Trujillo-Benitez D, Luna-Gutierrez M, Ferro-Flores G, Ocampo-Garcia B, Santos-Cuevas C, Bravo-Villegas G, Morales-Avila E, Cruz-Nova P, Diaz-Nieto L, Garcia-Quiroz J, Azorin-Vega E, Rosato A, Melendez-Alafort L. Design, Synthesis and Preclinical Assessment of 99mTc-iFAP for In Vivo Fibroblast Activation Protein (FAP) Imaging. Molecules. 2022 Jan 1;27(1):264. doi: 10.3390/molecules27010264.
PubMed 35011496Boschi A, Urso L, Uccelli L, Martini P, Filippi L. 99mTc-labeled FAPI compounds for cancer and inflammation: from radiochemistry to the first clinical applications. EJNMMI Radiopharm Chem. 2024 May 2;9(1):36. doi: 10.1186/s41181-024-00264-0.
PubMed 38695960
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of 99mTc-FDPH46 SPECT/CT Imaging in Malignant Solid Tumor: a Prospective Exploratory Study
- ClinicalTrials.gov ID
- NCT06753513
- Acronym / sponsor ID
- 99mTc；FAPI；mCi / IIT20240134C-R1
- Conditions
- Malignant Tumors, Solid Tumor Malignancy
- Keywords
- 99mTc, FDPH46, SPECT, Malignant Solid Tumor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University
- Study start
- 28 Dec 2024 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Dec 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.
The goal of this observational study aims to preliminarily evaluate the diagnostic efficacy of 99mTc-FDPH46 SPECT/CT in malignant solid tumors (compared to the pathological gold standard). The main questions it aims to answer are:
- What is the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors, compared to the pathological gold standard?
- What is the biodistribution, tumor uptake and safety of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors?
Participant Will:
- Patients with clinically suspected or diagnosed malignant solid tumors who are willing to undergo 99mTc-FDPH46 SPECT/CT examination and sign an informed consent form.
Detailed description
Patients who are clinically assessed as suspected or diagnosed with malignant solid tumors will receive an intravenous injection of 20-25mCi of 99mTc-FDPH46. Whole-body planar scintigraphy will be performed at 10, 30, 90, 150, and 240 minutes post-injection to obtain dynamic biodistribution images. Additionally, 99mTc-FDPH46 SPECT/CT imaging will be conducted 60-90 minutes after the intravenous injection to acquire both whole-body planar scintigraphy and SPECT/CT tomographic fusion images. After the scans are completed, patients will be observed in the waiting room for 1 hour before they are allowed to return.During the follow-up visit after the examination, the researchers will collect the patients' clinical information and any changes in symptoms, and record them in the medical records. All subjects will be followed up once on the same day after the SPECT/CT scan and again one week later.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Self-Control | – | Other: 99mTc-FDPH46 SPECT/CT ImagingPatient Self-Control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are clinically suspected or diagnosed with malignant solid tumors.
Key inclusion criteria (4 listed)
- Patients who are clinically suspected or diagnosed with malignant solid tumors.
- Ages between 18 to 80 years old.
- Stable vital signs, ECOG score of 0-2, capable of tolerating and cooperating with the 99mTc-FDPH46 SPECT/CT examination.
- Subjects who are willing to undergo the 99mTc-FDPH46 SPECT/CT examination and have signed the informed consent form.
Key exclusion criteria (3 listed)
- Those who can not understand, comply with the research protocol or are unable to sign the informed consent form.
- Contraindications for SPECT imaging (including pregnant women, nursing women, women of childbearing age with recent plans to conceive, etc.).
- Unstable vital signs, ECOG score >2, unable to tolerate or cooperate with the 99mTc-FDPH46 SPECT/CT examination process.
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 |
|---|---|---|
| 99mTc-FDPH46 SPECT/CT Imaging99mTc-FDPH46 SPECT/CT Imaging | Other | Patient Self-Control |
Primary outcome
Compared with the pathological gold standard, assess the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors.
Time frame: 2024.12-2026.10
Using the pathological gold standard as a reference, the sensitivity, specificity, positive predictive value, and negative predictive value of 99mTc-FDPH46 in patients with malignant solid tumors were evaluated. The consistency between the two diagnostic methods was assessed by Kappa analysis, thereby determining the diagnostic efficacy of 99mTc-FDPH46 in patients with malignant solid tumors.
1 secondary outcome
Assess the safety, biodistribution, and tumor uptake of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors.
Time frame: 2024.12-2026.12
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 31 Dec 2024.
- Results publication: PubMed 34904839Ruan Q, Feng J, Jiang Y, Zhang X, Duan X, Wang Q, Yin G, Xiao D, Zhang J. Preparation and Bioevaluation of 99mTc-Labeled FAP Inhibitors as Tumor Radiotracers to Target the Fibroblast Activation Protein. Mol Pharm. 2022 Jan 3;19(1):160-171. doi: 10.1021/acs.molpharmaceut.1c00712. Epub 2021 Dec 14.
- Results publication: PubMed 37083360Ruan Q, Zhou C, Wang Q, Kang F, Jiang Y, Li G, Feng J, Zong S, Zhang J, Wang J. A Simple Kit Formulation for Preparation and Exploratory Human Studies of a Novel 99mTc-Labeled Fibroblast Activation Protein Inhibitor Tracer for Imaging of the Fibroblast Activation Protein in Cancers. Mol Pharm. 2023 Jun 5;20(6):2942-2950. doi: 10.1021/acs.molpharmaceut.2c01094. Epub 2023 Apr 21.
- Results publication: PubMed 36972467Ruan Q, Wang Q, Jiang Y, Feng J, Yin G, Zhang J. Synthesis and Evaluation of 99mTc-Labeled FAP Inhibitors with Different Linkers for Imaging of Fibroblast Activation Proteins in Tumors. J Med Chem. 2023 Apr 13;66(7):4952-4960. doi: 10.1021/acs.jmedchem.2c02062. Epub 2023 Mar 27.
- Results publication: PubMed 38320123Ruan Q, Ding D, Diao L, Feng J, Yin G, Jiang Y, Wang Q, Han P, Jiang J, Zhang J. Synthesis and Preclinical Evaluation of Novel 99mTc-Labeled FAPI-46 Derivatives with Significant Tumor Uptake and Improved Tumor-to-Nontarget Ratios. J Med Chem. 2024 Feb 22;67(4):3190-3202. doi: 10.1021/acs.jmedchem.4c00031. Epub 2024 Feb 6.
- Results publication: PubMed 32169911Lindner T, Altmann A, Kramer S, Kleist C, Loktev A, Kratochwil C, Giesel F, Mier W, Marme F, Debus J, Haberkorn U. Design and Development of 99mTc-Labeled FAPI Tracers for SPECT Imaging and 188Re Therapy. J Nucl Med. 2020 Oct;61(10):1507-1513. doi: 10.2967/jnumed.119.239731. Epub 2020 Mar 13.
- Results publication: PubMed 37895905Liu Y, Zhang Q, Zhang Y, Wang J, Wu Y, Yang G, Shi J, Wang F, Xu Z, Jing H. 99mTc-Labeled FAPI SPECT Imaging in Idiopathic Pulmonary Fibrosis: Preliminary Results. Pharmaceuticals (Basel). 2023 Oct 9;16(10):1434. doi: 10.3390/ph16101434.
- Results publication: PubMed 36986521Luo X, Zhang Z, Cheng C, Wang T, Fang D, Zuo C, Yuan G, Li R, Li X. SPECT Imaging with Tc-99m-Labeled HYNIC-FAPI-04 to Extend the Differential Time Window in Evaluating Tumor Fibrosis. Pharmaceuticals (Basel). 2023 Mar 10;16(3):423. doi: 10.3390/ph16030423.
- Results publication: PubMed 36879039Jiang Y, Tian Y, Feng B, Zhao T, Du L, Yu X, Zhao Q. A novel molecular imaging probe [99mTc]Tc-HYNIC-FAPI targeting cancer-associated fibroblasts. Sci Rep. 2023 Mar 6;13(1):3700. doi: 10.1038/s41598-023-30806-6.
- Results publication: PubMed 38193393Ma M, Yang G, Zhao M, Liu Y, Ge X, Jia B, Gao S. Synthesis and Preliminary Study of 99mTc-Labeled HYNIC-FAPi for Imaging of Fibroblast Activation Proteins in Tumors. Mol Pharm. 2024 Feb 5;21(2):735-744. doi: 10.1021/acs.molpharmaceut.3c00886. Epub 2024 Jan 9.
- Results publication: PubMed 36477400Jia X, Li X, Jia B, Yang Y, Wang Y, Liu Y, Ji T, Xie X, Yao Y, Qiu G, Deng H, Zhu Z, Chen S, Yang A, Gao R. The role of [99mTc]Tc-HFAPi SPECT/CT in patients with malignancies of digestive system: first clinical experience. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1228-1239. doi: 10.1007/s00259-022-06068-1. Epub 2022 Dec 7.
- Results publication: PubMed 35011496Trujillo-Benitez D, Luna-Gutierrez M, Ferro-Flores G, Ocampo-Garcia B, Santos-Cuevas C, Bravo-Villegas G, Morales-Avila E, Cruz-Nova P, Diaz-Nieto L, Garcia-Quiroz J, Azorin-Vega E, Rosato A, Melendez-Alafort L. Design, Synthesis and Preclinical Assessment of 99mTc-iFAP for In Vivo Fibroblast Activation Protein (FAP) Imaging. Molecules. 2022 Jan 1;27(1):264. doi: 10.3390/molecules27010264.
- Results publication: PubMed 38695960Boschi A, Urso L, Uccelli L, Martini P, Filippi L. 99mTc-labeled FAPI compounds for cancer and inflammation: from radiochemistry to the first clinical applications. EJNMMI Radiopharm Chem. 2024 May 2;9(1):36. doi: 10.1186/s41181-024-00264-0.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Malignant Tumors and Solid Tumor Malignancy, run by Zhejiang University 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 31 Dec 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 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 Zhang Jun (+（86）15088608182, 1505156@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compared with the pathological gold standard, assess the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors. (time frame: 2024.12-2026.10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06753513, which also lists 12 linked publications.
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 31 Dec 2024.