Clinical trial · Interventional
Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer
Comparison of Positron Nuclide Labeled DOTA-FAPI PET and FDG PET Study in Colocrectal Cancer
NCT04750772CI-TRIAL-00059311unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the normal physiological distribution of positron nuclide labeled DOTA-FAPI PET/CT in human body and its diagnostic efficiency for colorectal cancers
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Positron-Emission Tomography | — | UNRESOLVED | — |
| Tumor, Solid | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG and 18F-DOTA-FAPI04 PET/CT | Diagnostic Test | — | UNRESOLVED |
| 18F-FDG and 68Ga-DOTA-FAPI04 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 68Ga-DOTA-FAPI04
- description
- Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI04, and undergo PET/CT imaging within the specified time
- interventionNames
- Diagnostic Test: 18F-FDG and 68Ga-DOTA-FAPI04 PET/CT
- type
- EXPERIMENTAL
- label
- 18F-DOTA-FAPI04
- description
- Each subject receive a single intravenous injection of 18F-FDG and 18F-DOTA-FAPI04, and undergo PET/CT imaging within the specified time
- interventionNames
- Diagnostic Test: 18F-FDG and 18F-DOTA-FAPI04 PET/CT
Primary outcomes (1)
- measure
- finial clinical staging(TNM)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG score 0-2 * patients with newly diagnosed or previously treated colorectal cancers * patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for tumor staging to decide the most proper treatment strategy * patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT to detect tumor recurrence and metastases (repeat staging) * expected survival ≥12 weeks * blood routine, liver and kidney function meet the following criteria : blood routine: WBC≥4.0×109L or neutrophils ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L;PT and APTT ULN 1.5 or less; Liver and kidney function: t-bil ≤1.5×ULT(upper limit of normal value), ALT/AST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis);BUN 1.5 x or less ULT, SCr 1.5 x or less ULT * at least one measurable target lesion according to RECIST1.1 * women must use effective contraception during the study period and for 6 months after the end of the study (effective contraception means sterilization, hormone devices, condoms, contraceptives/pills, abstinence or vasectomy by a partner, etc.);Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period * able to understand and sign the informed consent voluntarily, with good compliance. Exclusion Criteria: * severe abnormalities of liver and kidney function; * women preparing for pregnancy, pregnancy and lactation; * cannot lie supine for half an hour; * refuse to join the clinical researcher; * suffering from claustrophobia or other mental illness;
References
Publications (10)
- BACKGROUNDLoktev A, Lindner T, Burger EM, Altmann A, Giesel F, Kratochwil C, Debus J, Marme F, Jager D, Mier W, Haberkorn U. Development of Fibroblast Activation Protein-Targeted Radiotracers with Improved Tumor Retention. J Nucl Med. 2019 Oct;60(10):1421-1429. doi: 10.2967/jnumed.118.224469. Epub 2019 Mar 8. PMID 30850501
- RESULTSiegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8. PMID 31912902
- RESULTDekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0. PMID 31631858
- RESULTChakedis J, Schmidt CR. Surgical Treatment of Metastatic Colorectal Cancer. Surg Oncol Clin N Am. 2018 Apr;27(2):377-399. doi: 10.1016/j.soc.2017.11.010. Epub 2017 Dec 15. PMID 29496096
- RESULTKantorova I, Lipska L, Belohlavek O, Visokai V, Trubac M, Schneiderova M. Routine (18)F-FDG PET preoperative staging of colorectal cancer: comparison with conventional staging and its impact on treatment decision making. J Nucl Med. 2003 Nov;44(11):1784-8. PMID 14602860
- RESULTPetersen RK, Hess S, Alavi A, Hoilund-Carlsen PF. Clinical impact of FDG-PET/CT on colorectal cancer staging and treatment strategy. Am J Nucl Med Mol Imaging. 2014 Aug 15;4(5):471-82. eCollection 2014. PMID 25143865
- RESULTBerger KL, Nicholson SA, Dehdashti F, Siegel BA. FDG PET evaluation of mucinous neoplasms: correlation of FDG uptake with histopathologic features. AJR Am J Roentgenol. 2000 Apr;174(4):1005-8. doi: 10.2214/ajr.174.4.1741005. PMID 10749239
- RESULTBorello A, Russolillo N, Lo Tesoriere R, Langella S, Guerra M, Ferrero A. Diagnostic performance of the FDG-PET/CT in patients with resected mucinous colorectal liver metastases. Surgeon. 2021 Oct;19(5):e140-e145. doi: 10.1016/j.surge.2020.09.004. Epub 2020 Oct 23.