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18FAl-NOTA-HER2 Affibody PET imaging in HER2 positive tumors

18FAl-NOTA-HER2 Affibody PET imaging in HER2 positive tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000029195
Enrollment
Unknown
Registered
2020-01-18
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Interventions

Gold Standard:Pathological examination
18FAl-NOTA-HER2&#32
Affibody (2)&#32
18F-FDG

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 year; ECoG 0 or 1; 2. patients with histologic confirmed HER2 positive breast cancer, gastric cancer or other tumors or suspected tumors who are to undergo pathological biopsy or tumor surgical treatment (within 2 months); 3. life expectancy >=12 weeks; 4. Blood routine test and liver and kidney function criteria: blood routine test: WBC >=4.0x10^9/L or neutrophil >= 1.5x10^9/L, PLT >=100x10^9/L, Hb >=90g/L; Pt or APTT <=1.5 ULN; liver and kidney function: T-Bil <=1.5 ULN, ALT / AST <=2.5 ULN or <=5 ULN (subjects with liver metastasis), ALP <=2.5 ULN (if there is bone metastasis or liver metastasis, ALP <=4.5 ULN); bun <=1.5 ULN, SCR <=1 .5 ULN; 5. With at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1); 6. During the study period and 6 months after the end of the study, female patients must adopt effective contraceptive measures (effective contraceptive measures refer to sterilization, hormone device in the child's office, condom, contraceptive / agent, abstinence or partner's vasectomy, etc.); male patients should adopt contraceptive measures during the study period and 6 months after the end of the study period; 7. Able to understand and sign the informed consent with good compliance.

Exclusion criteria

Exclusion criteria: 1) Significant hepatic or renal dysfunction; 2) Pregnant or ready to pregnancy; 3) Cannot lie on their back for half an hour; 4) Refusal to join the clinical study; 5) Suffering from claustrophobia or other mental diseases; 6) Any other situation that researchers think it is not suitable to participate in the experiment.

Design outcomes

Primary

MeasureTime frame
SUVmax;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactZhu Hua

Beijing Cancer Hospital

zhuhuananjing@163.com+86 010 88196495

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026