NCT06270394

Brief Summary

This clinical trial aims to investigate the value of fibroblast activation protein PET/CT(PET/MR) in the diagnosis, staging, and evaluation of treatment outcomes in malignant tumors. The main question it aims to answer is: Fibroblast Activation Protein PET/CT(PET/MR) whether or in which cases this assay is superior to conventional FDG examination in the diagnosis, staging, and assessment of therapeutic efficacy of malignant tumors, thinking about the reasons behind this. Investigators will screen suitable participants among patients undergoing routine FDG examination.

  • Participants will sign an informed consent form
  • Undergo 68Ga-FAPI PET/CT (PET/MR) before surgery or biopsy
  • Surgical resection or puncture biopsy to obtain pathologic results. Diagnosis of patients with malignant tumors at first diagnosis; clinical staging of tumors; and clinical outcomes of patients with confirmed diagnoses will be assessed after postoperative investigator follow-up. The researchers will compare the FDG exams the participants have had to determine the effectiveness of the fibroblast activating protein test.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

January 23, 2024

Last Update Submit

August 8, 2025

Conditions

Malignant TumorsPositron-Emission Tomography

Keywords

FAPIPET/CTPET/MRIMalignant Tumors

Outcome Measures

Primary Outcomes (1)

  • 68Ga-Fibroblast Activation Protein Inhibitor-04 Uptake in Gastrointestinal Cancer: Comparison with 18F-FDG

    18F-FDG PET/CT and 68Ga-FAPI-04 PET/MR scans were acquired independently for all the participants with pathologically confirmed GI tumors and signs. The χ2 test was used to analyze these two technologies to quantitatively compare the diagnostic effects. The normalized SUVmax values (calculated by dividing a lesion's original SUVmax by the SUVmean of the descending aorta) of selected lesions were measured and analyzed by Student's t-test. A visual assessment system of the regions was prepared.

    up to 38 months

Secondary Outcomes (1)

  • Utility of 68Ga-FAPI-04 PET/MRI combines 18F-FDG PET/CT in the postoperative evaluation of gastrointestinal cancers

    up to 60 months

Study Arms (1)

68Ga-FAPI PET/MRI scan

EXPERIMENTAL

The 68Ge/68Ga generator was eluted with 0.1 M HCL solution to achieve 3.0 ml of liquid, which was mixed thoroughly with 20 µg FAPI precursor and 375 µl of 1.25 M sodium acetate. The mixture was placed in a thermostat at 95°C for 10 min. The finished liquid was passed through an activated Sep-pak 18C column and 0.8 ml of 80% ethanol was passed through the Sep-pak 18C column and a 0.2 µm microporous membrane (Pall Co., Ltd.) before the product was collected in a sterile product vial. The equipment scan pf PET/MRI is the SIGNA PET/MR manufactured by GE Healthcare. The scan is performed approximately 40 min after injection of 1.85-3.7 MBq 68Ga-FAPI-04 per kg body weight. Breath-gated corrected step-and-shoot (SS) acquisition mode was used. The scan time was 60 ± 10 min (50-70 min). Dedicated T1- and T2-weighted images and diffusion-weighted images (DWI) of the head and neck, chest, abdomen, and pelvis were acquired.

Drug: 68Ga-Fibroblast activation protein inhibitor

Interventions

68Ga-Fibroblast activation protein inhibitorDRUG

Fibroblast activation protein (FAP), a type II transmembrane serine protease with dipeptidyl peptidase and endopeptidase activities. FAP is a specific surface marker for activated fibroblasts in the mesenchyme of tumors, which account for 90% of the stroma of epithelial neoplasms. FAP inhibitors (FAPIs) can specifically target and bind to FAP. These inhibitors that are radiolabeled with gallium 68 (68Ga-FAPIs) can be probes for visualization of the FAP tumor stroma. Previous studies have demonstrated that 68Ga-FAPI-04 is not dependent on blood glucose levels, has an equal or better tumor-to-background ratio, and clearly visualizes primary tumors and their metastatic foci. In addition, previous studies on 68Ga-FAPI-04 have focused on PET/CT and the efficacy of PET/MR with FAPI for postoperative evaluation of GI tumors remains to be clarified.

Also known as: PET-MRI (SIGNA PET/MR manufactured by GE Healthcare)
68Ga-FAPI PET/MRI scan

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years ≤ 75 years of age;
  • Patients with clinical suspicion of malignancy;
  • No invasive tests or treatments recently;
  • Blood routine: leukocyte \> 4×109/L, neutrophil \> 2×10 9/L, hemoglobin \> 90g/L, platelets \> 100×10 9/L;
  • Cardiac function: left ventricular ejection fraction \>50%;
  • Pulmonary function tests: FEV1 ≥1.2L, FEV1% ≥50% and DLCO ≥50%;
  • Liver function: total bilirubin \<1.5 times upper limit of normal (ULN); AST and ALT \<1.5 times ULN;
  • Renal function: serum creatinine ≤ 1.5 times ULN, or glomerular filtration rate \> 60 ml/min;
  • Participants agreed to participate in this clinical trial and signed an informed consent form;
  • Good compliance and commitment to follow the study procedures and to cooperate in the implementation of the full study;
  • No birth plans for six months.

You may not qualify if:

  • Those with severe psychiatric symptoms, or those who are too confused to cooperate with the examination;
  • Pregnant and potentially pregnant women, lactating women;
  • Those with poor compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FirstHAnhuiMU

Hefei, Anhui, 230032, China

Location

Related Publications (17)

  • Warburg O, Wind F, Negelein E. THE METABOLISM OF TUMORS IN THE BODY. J Gen Physiol. 1927 Mar 7;8(6):519-30. doi: 10.1085/jgp.8.6.519. No abstract available.

    PMID: 19872213BACKGROUND

  • Mankoff DA, Eary JF, Link JM, Muzi M, Rajendran JG, Spence AM, Krohn KA. Tumor-specific positron emission tomography imaging in patients: [18F] fluorodeoxyglucose and beyond. Clin Cancer Res. 2007 Jun 15;13(12):3460-9. doi: 10.1158/1078-0432.CCR-07-0074.

    PMID: 17575208BACKGROUND

  • Chang JM, Lee HJ, Goo JM, Lee HY, Lee JJ, Chung JK, Im JG. False positive and false negative FDG-PET scans in various thoracic diseases. Korean J Radiol. 2006 Jan-Mar;7(1):57-69. doi: 10.3348/kjr.2006.7.1.57.

    PMID: 16549957BACKGROUND

  • Cheng JD, Valianou M, Canutescu AA, Jaffe EK, Lee HO, Wang H, Lai JH, Bachovchin WW, Weiner LM. Abrogation of fibroblast activation protein enzymatic activity attenuates tumor growth. Mol Cancer Ther. 2005 Mar;4(3):351-60. doi: 10.1158/1535-7163.MCT-04-0269.

    PMID: 15767544BACKGROUND

  • Pineiro-Sanchez ML, Goldstein LA, Dodt J, Howard L, Yeh Y, Tran H, Argraves WS, Chen WT. Identification of the 170-kDa melanoma membrane-bound gelatinase (seprase) as a serine integral membrane protease. J Biol Chem. 1997 Mar 21;272(12):7595-601. doi: 10.1074/jbc.272.12.7595.

    PMID: 9065413BACKGROUND

  • Huber MA, Kraut N, Park JE, Schubert RD, Rettig WJ, Peter RU, Garin-Chesa P. Fibroblast activation protein: differential expression and serine protease activity in reactive stromal fibroblasts of melanocytic skin tumors. J Invest Dermatol. 2003 Feb;120(2):182-8. doi: 10.1046/j.1523-1747.2003.12035.x.

    PMID: 12542520BACKGROUND

  • Henry LR, Lee HO, Lee JS, Klein-Szanto A, Watts P, Ross EA, Chen WT, Cheng JD. Clinical implications of fibroblast activation protein in patients with colon cancer. Clin Cancer Res. 2007 Mar 15;13(6):1736-41. doi: 10.1158/1078-0432.CCR-06-1746.

    PMID: 17363526BACKGROUND

  • Shi M, Yu DH, Chen Y, Zhao CY, Zhang J, Liu QH, Ni CR, Zhu MH. Expression of fibroblast activation protein in human pancreatic adenocarcinoma and its clinicopathological significance. World J Gastroenterol. 2012 Feb 28;18(8):840-6. doi: 10.3748/wjg.v18.i8.840.

    PMID: 22371645BACKGROUND

  • Goscinski MA, Suo Z, Florenes VA, Vlatkovic L, Nesland JM, Giercksky KE. FAP-alpha and uPA show different expression patterns in premalignant and malignant esophageal lesions. Ultrastruct Pathol. 2008 May-Jun;32(3):89-96. doi: 10.1080/01913120802034934.

    PMID: 18570153BACKGROUND

  • Lai D, Ma L, Wang F. Fibroblast activation protein regulates tumor-associated fibroblasts and epithelial ovarian cancer cells. Int J Oncol. 2012 Aug;41(2):541-50. doi: 10.3892/ijo.2012.1475. Epub 2012 May 14.

    PMID: 22614695BACKGROUND

  • Rasanen K, Virtanen I, Salmenpera P, Grenman R, Vaheri A. Differences in the nemosis response of normal and cancer-associated fibroblasts from patients with oral squamous cell carcinoma. PLoS One. 2009 Sep 1;4(9):e6879. doi: 10.1371/journal.pone.0006879.

    PMID: 19721715BACKGROUND

  • Dohi O, Ohtani H, Hatori M, Sato E, Hosaka M, Nagura H, Itoi E, Kokubun S. Histogenesis-specific expression of fibroblast activation protein and dipeptidylpeptidase-IV in human bone and soft tissue tumours. Histopathology. 2009 Oct;55(4):432-40. doi: 10.1111/j.1365-2559.2009.03399.x.

    PMID: 19817894BACKGROUND

  • Cheng JD, Dunbrack RL Jr, Valianou M, Rogatko A, Alpaugh RK, Weiner LM. Promotion of tumor growth by murine fibroblast activation protein, a serine protease, in an animal model. Cancer Res. 2002 Aug 15;62(16):4767-72.

    PMID: 12183436BACKGROUND

  • Liu R, Li H, Liu L, Yu J, Ren X. Fibroblast activation protein: A potential therapeutic target in cancer. Cancer Biol Ther. 2012 Feb 1;13(3):123-9. doi: 10.4161/cbt.13.3.18696. Epub 2012 Feb 1.

    PMID: 22236832BACKGROUND

  • Giesel FL, Kratochwil C, Lindner T, Marschalek MM, Loktev A, Lehnert W, Debus J, Jager D, Flechsig P, Altmann A, Mier W, Haberkorn U. 68Ga-FAPI PET/CT: Biodistribution and Preliminary Dosimetry Estimate of 2 DOTA-Containing FAP-Targeting Agents in Patients with Various Cancers. J Nucl Med. 2019 Mar;60(3):386-392. doi: 10.2967/jnumed.118.215913. Epub 2018 Aug 2.

    PMID: 30072500BACKGROUND

  • Hathi DK, Jones EF. 68Ga FAPI PET/CT: Tracer Uptake in 28 Different Kinds of Cancer. Radiol Imaging Cancer. 2019 Sep 27;1(1):e194003. doi: 10.1148/rycan.2019194003. eCollection 2019 Sep. No abstract available.

    PMID: 33778675BACKGROUND

  • Loktev 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: 30850501BACKGROUND

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Huiqin Xu

    The First Affiliated Hospital of Anhui Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 21, 2024

Study Start

April 28, 2022

Primary Completion

November 28, 2023

Study Completion

May 31, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The datasets generated during and/or analyzed during the current study are available from the Study Chair upon reasonable request.

Locations

CN(1)